US goal to be ‘first’ on de­vices wor­ries for­mer reg­u­la­tors

The Standard Journal - - LOCAL - By Matthew Per­rone AP Health Writer

Dr. Jef­frey Shuren was adamant: The United States would never cut cor­ners to fast-track the ap­proval of med­i­cal de­vices.

“We don’t use our peo­ple as guinea pigs in the U.S.,” Shuren said, hold­ing firm as the new di­rec­tor of the U.S. Food and Drug Ad­min­is­tra­tion’s med­i­cal de­vices di­vi­sion.

Again and again in 2011 — four times in all — Shuren was sum­moned be­fore Congress. Law­mak­ers ac­cused the agency of be­ing too slow and too de­mand­ing in re­view­ing new de­vices like heart valves and spinal im­plants, driv­ing U.S. man­u­fac­tur­ers over­seas where prod­ucts faced less rig­or­ous re­view. Each time, he pushed back. And yet the next year, Shuren and his team adopted an ap­proach that sur­prised even some of his clos­est col­leagues: The FDA would strive to be “first in the world” to ap­prove de­vices it con­sid­ered im­por­tant to pub­lic health.

The agency’s shift mir­rored the talk­ing points of the $400 bil­lion med­i­cal de­vice in­dus­try — a lob­by­ing be­he­moth on Capi­tol Hill — and ush­ered in a se­ries of changes that crit­ics say have al­lowed man­u­fac­tur­ers to seek reg­u­la­tory ap­proval for high-risk de­vices us­ing smaller, shorter, less rig­or­ous stud­ies that pro­vide less cer­tainty of safety and ef­fec­tive­ness.

Un­der Shuren, an­nual new de­vice ap­provals have more than tripled, while warn­ings let­ters to de­vice man­u­fac­tur­ers about prod­uct safety and qual­ity is­sues have fallen roughly 80 per­cent, an As­so­ci­ated Press in­ves­ti­ga­tion found.

The as­sort­ment of med­i­cal de­vices now on the mar­ket in­cludes spinal rods that can leave metal shards in chil­dren and a nervezap­ping obe­sity im­plant that may not work for many pa­tients.

The cheaper and faster med­i­cal de­vice ap­provals be­gan de­spite mul­ti­ple, high-pro­file safety prob­lems in­volv­ing pelvic mesh, hip re­place­ments and other im­plants.

An AP anal­y­sis of FDA data shows that since 2012, tens of thou­sands of in­jury and death re­ports have been filed in con­nec­tion with de­vices that were cleared through a stream­lined path­way that min­i­mizes clin­i­cal trial test­ing.

The FDA’s data­base for re­port­ing de­vice prob­lems of­ten in­cludes in­com­plete, un­ver­i­fied in­for­ma­tion sub­mit­ted by man­u­fac­tur­ers, physi­cians, lawyers and pa­tients. Be­cause of these lim­i­ta­tions, it’s of­ten un­clear whether a de­vice played any role in an in­jury or death.

In re­sponse to ques­tions from the AP, the FDA said its “first in the world” goal was not about a com­pe­ti­tion with other coun­tries but rather was adopted as part of a strat­egy that also fo­cused on quickly iden­ti­fy­ing de­fec­tive prod­ucts to en­sure U.S. de­vices “re­main safe, ef­fec­tive and of high qual­ity.”

The agency said it has fo­cused on tak­ing steps to re­duce the time and cost of de­vice de­vel­op­ment “that do not com­pro­mise our stan­dard of rea­son­able as­sur­ance of safety and ef­fec­tive­ness.”

Warn­ing let­ters have de­clined, the FDA said, be­cause the agency is us­ing a new ap­proach that in­volves fewer warn­ings but more in­spec­tions to over­see com­pa­nies that vi­o­late its rules.

In past weeks, the FDA an­nounced a new goal to be “con­sis­tently first” among the world’s reg­u­la­tory agen­cies to iden­tify and ad­dress med­i­cal de­vice safety is­sues.

The agency also re­jected the idea that Shuren’s ap­proach to reg­u­la­tion has changed over time, say­ing he has worked for years to im­prove pa­tient safety.

Still, some cur­rent and for­mer FDA of­fi­cials are wor­ried about the am­bi­tion to be first on ap­provals.

They in­clude Dr. Peter Lurie, who calls the agency’s new di­rec­tion “an in­vi­ta­tion to a race to the bot­tom for sci­en­tific stan­dards” seem­ingly prompted by in­dus­try pres­sure. Lurie held se­nior posts at FDA from 2009 to 2017 and now heads the non­profit Cen­ter for Science in the Pub­lic In­ter­est.

The FDA’s med­i­cal de­vice stan­dards are still con­sid­ered among the high­est in the world, re­quir­ing “rea­son­able as­sur­ance” of both safety and ef­fec­tive­ness. But by try­ing to out­pace coun­tries with less strin­gent re­quire­ments, Lurie said, the FDA has opened the door to low­er­ing its own stan­dards to achieve its goal.

The FDA’s strug­gle to find the right mix of reg­u­la­tion and in­no­va­tion in over­see­ing more than 190,000 med­i­cal de­vices — from pace­mak­ers to con­tact lenses to sur­gi­cal ro­bots — has been chron­i­cled for decades by gov­ern­ment in­spec­tors and out­side re­searchers.

For al­most as long, the agency has had a sym­bi­otic re­la­tion­ship with in­dus­try.

Fees paid by med­i­cal de­vice man­u­fac­tur­ers for the re­view of their prod­ucts now cover about 35 per­cent of the an­nual bud­get of the agency’s Cen­ter for De­vices and Ra­di­o­log­i­cal Health. The last four of­fi­cials in Shuren’s po­si­tion have gone on to higher-paid po­si­tions in in­dus­try.

In ad­di­tion, Shuren’s wife, Al­li­son, is a for­mer lob­by­ist who now leads her law firm’s health-care prac­tice group and ad­vises med­i­cal de­vice clients, among oth­ers, on reg­u­la­tory and leg­isla­tive is­sues.

The FDA said Shuren passed a “rig­or­ous ethics re­view process” be­fore as­sum­ing his po­si­tion that ad­dressed po­ten­tial con­flicts of in­ter­est. He also re­cuses him­self from FDA mat­ters in­volv­ing clients rep­re­sented by his wife or her firm, the agency said.

Joshua Sharf­stein, a for­mer FDA deputy com­mis­sioner now teach­ing at Johns Hop­kins Univer­sity, praised Shuren for bal­anc­ing the com­pet­ing de­mands of pro­tect­ing the pub­lic while promptly ap­prov­ing ben­e­fi­cial new de­vices.

“I don’t think there’s a vi­able way to be the head of de­vices and be in open war­fare with in­dus­try all the time,” he said.

But some who spent years work­ing un­der Shuren say speed­ing up prod­uct re­views be­came the clear pri­or­ity af­ter 2012.

“Ba­si­cally, it was ‘We need to find ways to get prod­ucts on the mar­ket quicker, faster and we need to fig­ure out how to re­duce the pre­mar­ket data re­quire­ments,’” said Christy Fore­man, an in­dus­try con­sul­tant who spent 22 years at the FDA, in­clud­ing four years lead­ing its de­vice re­view of­fice.

The FDA notes that laws passed by Congress re­quire the agency to em­pha­size the “least bur­den­some ap­proach” to re­view­ing new de­vices. But the agency it­self helped fash­ion those laws, work­ing with in­dus­try lob­by­ists and law­mak­ers on pro­vi­sions that ef­fec­tively limit its abil­ity to re­quest ad­di­tional ev­i­dence from man­u­fac­tur­ers.

The phi­los­o­phy of “ac­cept­able uncer­tainty” is some­times the price of mak­ing life-saving de­vices quickly avail­able, ac­cord­ing to the FDA. At the same time, it ac­knowl­edges its main sys­tem for track­ing prob­lems is rid­dled with “in­com­plete, in­ac­cu­rate, un­timely, un­ver­i­fied or bi­ased data.”

“So in­stead, you have de­vices of un­known ben­e­fit on the mar­ket that still harm pa­tients,” said Dr. Rita Red­berg, a prom­i­nent med­i­cal re­searcher and car­di­ol­o­gist at the Univer­sity of Cal­i­for­nia San Fran­cisco. “I do feel that the FDA sees their role as mak­ing in­dus­try happy and not as much pro­tect­ing the pub­lic health.”

Ev­ery day, pa­tients in the U.S. and around the world ben­e­fit from med­i­cal tech­nol­ogy. The in­ven­tions of this global in­dus­try in­clude im­plants that help the deaf hear, im­plantable lenses that re­store sight to the el­derly and car­diac pumps that keep fail­ing hearts beat­ing.

For most of the last cen­tury, med­i­cal de­vices were not reg­u­lated in the U.S. But a se­ries of high-pro­file safety prob­lems in the 1970s — in­clud­ing deaths, mis­car­riages and in­juries caused by a con­tra­cep­tive im­plant — pushed Congress to in­ter­vene.

The laws that re­sulted are both more com­plex and less de­mand­ing than those gov­ern­ing drugs.

To win FDA ap­proval, for ex­am­ple, most new pre­scrip­tion drugs un­dergo two large, rig­or­ous clin­i­cal stud­ies prov­ing they ben­e­fit pa­tients. But most new med­i­cal de­vices en­ter the mar­ket with no clin­i­cal trial test­ing.

His­tor­i­cally, more than 95 per­cent of FDA-re­viewed de­vices on the mar­ket went through a stream­lined process in which they need only show that they are “sub­stan­tially equiv­a­lent” to a prod­uct al­ready on the mar­ket. Typ­i­cally, only de­vices con­sid­ered high-risk, like heart pumps, must demon­strate safety and ef­fec­tive­ness in hu­mans, but even those can some­times rely on ex­ist­ing sci­en­tific data as op­posed to new stud­ies.

On Nov. 26, the FDA pro­posed changes to the stream­lined sys­tem that would push man­u­fac­tur­ers to in­cor­po­rate more up-to-date tech­nol­ogy into their de­vices. But some of the ma­jor re­forms could take years to im­ple­ment.

Some ex­perts have long ar­gued that this fast-track path­way was never in­tended to be per­ma­nent. As framed by Congress in 1976, the sys­tem was orig­i­nally meant to be a tem­po­rary way to grand­fa­ther in thou­sands of de­vices al­ready on the mar­ket that weren’t con­sid­ered high-enough risk to re­quire im­me­di­ate re­view. But in­stead of be­ing phased out, it be­came main­stream.

The in­dus­try con­tends that flex­i­bil­ity is crit­i­cal to in­no­va­tion, al­low­ing man­u­fac­tur­ers to quickly and cheaply ex­per­i­ment and im­prove. An FDA re­view un­der that process costs about $11,000, com­pared to $320,000, un­der the more rig­or­ous stan­dard.

The re­sult, though, is that some med­i­cal prod­ucts barely re­sem­ble the decades-old “pred­i­cates” they ref­er­ence in ap­ply­ing for FDA clear­ance. And even when old de­vices have been linked to in­juries or death, fu­ture prod­ucts are al­lowed to ref­er­ence them for ap­proval be­cause the FDA lacks ex­plicit le­gal au­thor­ity to swiftly in­ter­vene.

In more than four decades, the FDA has banned only two prod­ucts — pow­dered sur­gi­cal gloves, which caused al­ler­gic re­ac­tions in pa­tients, and fake hair im­plants, which caused in­fec­tions and didn’t work. The agency says its abil­ity to ban prod­ucts is “bound by fed­eral law” and is es­sen­tially lim­ited to de­vices that are ei­ther de­cep­tively mar­keted or un­rea­son­ably dan­ger­ous.

The U.S. de­vice sys­tem is “ba­si­cally set up to get things on the mar­ket, not to get things off the mar­ket,” said Larry Kessler, a Univer­sity of Wash­ing­ton pro­fes­sor and con­sul­tant who worked more than a decade in the FDA’s de­vice cen­ter.

A de­vice used to treat child­hood sco­l­io­sis il­lus­trates how quickly man­u­fac­tur­ers can win FDA ap­proval with min­i­mal clin­i­cal trial test­ing.

The MAGEC rod uses re­mote­con­trolled mag­nets to grad­u­ally ex­tend ti­ta­nium columns im­planted in chil­dren’s backs to cor­rect de­bil­i­tat­ing spinal cur­va­ture. It is mar­keted as an al­ter­na­tive to tra­di­tional im­plants, which re­quire fre­quent surg­eries to man­u­ally ex­tend the rods as a child grows.

Prior to clear­ing it for use in the United States, the FDA al­lowed the MAGEC rod’s Cal­i­for­nia-based man­u­fac­turer, El­lipse, to be­gin ex­port­ing its prod­uct over­seas.

The com­pany en­listed a Hong Kong sur­geon to con­duct its first hu­man tri­als af­ter win­ning Euro­pean ap­proval in 2009 fol­low­ing ex­per­i­ments in pigs. In a com­pany-funded study pub­lished three years later — based on the re­sults of just two pa­tients — the sur­geon con­cluded the MAGEC rod “im­proves qual­ity of life and is more cost-ef­fec­tive.” The rods were later im­planted in pa­tients in Aus­tralia, Is­rael, Ko­rea and else­where.

The com­pany had as­sumed it would need to con­duct a large clin­i­cal study in­clud­ing Amer­i­can chil­dren to win FDA ap­proval for use in the United States, Dr. Behrooz Ak­bar­nia, a San Diegob­ased sur­geon and com­pany con­sul­tant, said in an in­ter­view.

But in early 2014, the FDA in­formed the com­pany it could seek ap­proval via the stream­lined process, Ak­bar­nia said. El­lipse claimed its de­vice was “sub­stan­tially equiv­a­lent” to a me­chan­i­cal im­plant de­vel­oped in the 1950s. It was cleared for use in the U.S. by the FDA in just 35 days.

“That was one of the things that sur­prised me,” Ak­bar­nia said, “be­cause it was so fast.”

The ap­proval also “shocked the spine in­dus­try,” ac­cord­ing to an ar­ti­cle by El­lipse’s for­mer vice pres­i­dent of en­gi­neer­ing Tiger Bu­ford, who did not re­spond to re­peated re­quests for an in­ter­view.

More than 2,000 chil­dren have been im­planted with MAGEC rods world­wide, ac­cord­ing to com­pany fil­ings by El­lipse, which was pur­chased by Nu­va­sive in 2016 for roughly $400 mil­lion.

An­thony Wai­ness was 9 when he be­came the first U.S. child to have MAGEC rods im­planted in 2013 un­der a “com­pas­sion­ate use” ex­emp­tion by the FDA. The rods tem­po­rar­ily helped the boy’s spine grow cor­rectly, but be­gan break­ing within a year and were re­moved in 2016.

An­thony’s doc­tors the­o­rized his body might be hav­ing an al­ler­gic re­ac­tion to the metal rods, ac­cord­ing to his fa­ther, Steven Wai­ness.

The FDA told the AP that the MAGEC rod was cleared based on lab­o­ra­tory test­ing, an­i­mal stud­ies and a clin­i­cal study “to demon­strate the de­vice is safe and ef­fec­tive.”

The agency said it re­quires mak­ers of all spinal im­plants to in­clude warn­ings about po­ten­tial risks, not­ing that the MAGEC rod’s la­bel­ing warns that it can break, move, cor­rode, cause pain and should not be used by pa­tients with metal al­ler­gies.

Re­searchers in Europe have iden­ti­fied cases of met­al­lo­sis in chil­dren with the rods, the tis­sue around their spines stained black by ti­ta­nium shards and de­bris.

The long-term ef­fects of ti­ta­nium met­al­lo­sis are not yet known, but metal de­bris in pa­tients with chrome and cobalt hip im­plants can cause bone and tis­sue dam­age. The all-metal hip im­plants, also cleared through the FDA’s stream­lined path to mar­ket, were im­planted in an es­ti­mated 500,000 Amer­i­cans be­fore the FDA re­clas­si­fied them as high-risk in 2016. To­day, they have largely been re­called or phased out.

In a pa­per pub­lished in Jan­uary in the med­i­cal jour­nal, Spine, British or­tho­pe­dic en­gi­neer Thomas Joyce said all 34 MAGEC rods ex­am­ined by his lab at New­cas­tle Univer­sity showed signs of metal wear, which could lead to de­bris spread­ing through­out chil­dren’s bod­ies.

The level of metal de­bris from MAGEC rods is about 100 times the lev­els he’d pre­vi­ously seen with hip im­plants, “a shock­ing amount,” he re­ported. Joyce has worked as an ex­pert wit­ness for lawyers su­ing metal hip mak­ers. He do­nates his pay­ment to his em­ployer, per univer­sity rules.

Nu­va­sive said in a state­ment that its de­vice has been shown to be ef­fec­tive in help­ing avoid the “pain, el­e­vated com­pli­ca­tion rates, and psy­cho­log­i­cal dis­tress” of tra­di­tional spinal rods.

“While no tech­nol­ogy in these pa­tients is without risk, we have also seen MAGEC re­build pa­tient and fam­ily lives,” the com­pany said.

Joyce said Nu­va­sive ini­tially co­op­er­ated with his research, pro­vid­ing ma­te­ri­als to help with his tests. But af­ter his research was pub­lished, he said the com­pany sent a let­ter to spine doc­tors world­wide ques­tion­ing its va­lid­ity.

Joyce said he’s sim­ply try­ing to an­swer ba­sic safety ques­tions that haven’t been ad­dressed by the com­pany or reg­u­la­tors: Why does the MAGEC rod cause met­al­lo­sis, and what are the long-term ef­fects on chil­dren?

A de­vice that claims to treat de­pres­sion by beam­ing rapid-fire bursts of mag­netic en­ergy into the brain’s pre­frontal cor­tex had a sim­i­larly smooth path to mar­ket, even though its ben­e­fits were un­clear.

Be­tween 2012 and 2016, for­mer U.S. mil­i­tary mem­bers par­tic­i­pated in a Depart­ment of Vet­er­ans Af­fairs study of the tran­scra­nial mag­netic stim­u­la­tion de­vice, or TMS. As of 2018, the VA has spent more than $3.4 mil­lion ac­quir­ing dozens of the ma­chines and re­lated sup­plies, based on the FDA’s ap­proval.

The FDA cleared TMS tech­nol­ogy for the U.S. mar­ket in 2008 even though the agency’s own ad­vis­ers said data sub­mit­ted by the orig­i­nal man­u­fac­turer failed to es­tab­lish its ef­fec­tive­ness. In fact, the ad­vis­ers called its ef­fect “mar­ginal,” ‘’bor­der­line” and “ques­tion­able.”

The ex­perts did note that TMS ther­apy ap­peared “rea­son­ably safe,” pro­duc­ing only mi­nor com­pli­ca­tions such as headaches and scalp pain. That com­pared fa­vor­ably to older de­vices used for hard-to-treat de­pres­sion, in­clud­ing elec­troshock ther­apy.

The FDA even­tu­ally ap­proved the de­vice through a path­way re­served for “low to moder­ate” risk de­vices that are not equiv­a­lent to pre­vi­ously ap­proved de­vices.

Un­der Shuren’s ten­ure, six more TMS man­u­fac­tur­ers have come on the mar­ket, mainly by piggy-back­ing off the orig­i­nal FDA clear­ance.

This June, when the VA pub­lished the find­ings of its study , they echoed the re­sults of a decade ear­lier: TMS made al­most no dif­fer­ence in pa­tients’ de­pres­sion. The au­thors of­fered sev­eral ex­pla­na­tions, in­clud­ing that vet­er­ans of­ten have mul­ti­ple psy­chi­atric prob­lems that com­pli­cate treat­ment.

The Amer­i­can Psy­chi­atric As­so­ci­a­tion’s guide­lines de­scribe TMS as of­fer­ing “rel­a­tively small to moder­ate ben­e­fits.” And even when TMS treat­ment is suc­cess­ful, its long-term dura­bil­ity has not been es­tab­lished in rig­or­ous pa­tient stud­ies.

Still, with per­sis­tent mar­ket­ing from man­u­fac­tur­ers, TMS has grad­u­ally won ac­cep­tance as an al­ter­na­tive to an­tide­pres­sants. Some clin­ics also ad­ver­tise un­ap­proved uses of the de­vice, in­clud­ing for autism, Alzheimer’s and post-trau­matic stress dis­or­der.

More than 800 U.S. clin­ics have the de­vices, ac­cord­ing to a fil­ing from the orig­i­nal TMS man­u­fac­turer, Neu­ro­net­ics Inc. The firm tells doc­tors they can re­coup the cost of a ma­chine by treat­ing just 12 pa­tients, with a typ­i­cal course of treat­ment cost­ing up to $10,000 for 30 or more ses­sions over four to six weeks.

“The clin­ics are pro­lif­er­at­ing, the in­surance is re­im­burs­ing, but we still don’t ex­actly know what kind of pa­tients should be re­ceiv­ing this in­ter­ven­tion,” said Dr. Dost On­gur, a Har­vard Med­i­cal School psy­chi­a­trist and edi­tor of the jour­nal that pub­lished the VA study.

TMS can be ef­fec­tive for cer­tain pa­tients, On­gur and other psy­chi­a­trists say, but iden­ti­fy­ing them can be chal­leng­ing.

The FDA said it ap­proved TMS af­ter de­ter­min­ing that its ben­e­fits out­weighed its risks. The de­vice’s ap­proval is lim­ited to pa­tients who have failed to re­spond to drug ther­apy with at least one an­tide­pres­sant, the agency said.

Neu­ro­net­ics said in a state­ment that its de­vice has been proven ef­fec­tive in stud­ies of more than 900 pa­tients and is cov­ered by more than 65 pri­vate in­sur­ers and the gov­ern­ment’s Medi­care plan. And Magven­ture, which makes the de­vice used in the VA study, said TMS’ im­pact on the brain is “a wellestab­lished fact,” though re­searchers are still ex­plor­ing the “op­ti­mal way” to treat dif­fer­ent pa­tient types.

But skep­tics re­main. The Blue Cross Blue Shield net­work’s unit for re­view­ing med­i­cal de­vices has as­sessed TMS three times, most re­cently con­clud­ing in 2014 that the stud­ies “do not pro­vide con­vinc­ing ev­i­dence.” The group is con­sid­ered a pi­o­neer in eval­u­at­ing med­i­cal tech­nol­ogy.

Fore­man, the for­mer FDA re­view chief, said the “least bur­den­some” re­quire­ments that bind FDA re­view­ers make it dif­fi­cult to de­mand bet­ter ev­i­dence for de­vices like TMS. In such cases, the agency’s po­si­tion is gen­er­ally “the de­vice isn’t go­ing to hurt any­body so let’s put it out there and let the con­sumer use it,” she said.

But even in­ef­fec­tive treat­ments for de­pres­sion can be harm­ful, ac­cord­ing to Diana Zuck­er­man, a de­pres­sion re­searcher and pres­i­dent of the non­profit Na­tional Cen­ter for Health Research, which as­sesses the qual­ity of out­side research and con­ducts its own.

“If you are go­ing five days a week for a month, spend­ing all this money and you feel you’re no bet­ter than when you started, you could end up more de­pressed,” Zuck­er­man says.

A new anal­y­sis of the TMS lit­er­a­ture by Zuck­er­man’s group con­cludes that the treat­ment “is not shown to be ben­e­fi­cial com­pared to typ­i­cal placebo ef­fects.”

One of the ra­tio­nales FDA cites for ac­cept­ing uncer­tainty in new de­vice safety and ef­fec­tive­ness is “pa­tient pref­er­ence,” which holds that the agency should con­sider pa­tient opin­ions in its ap­proval de­ci­sions.

For­mer FDA reg­u­la­tors say Shuren has re­pur­posed that idea to jus­tify putting even more de­vices on the mar­ket.

“Jeff tells won­der­ful sto­ries in terms of ‘We’re do­ing this to make sure pa­tients have this greatly im­proved tech­nol­ogy,’” Fore­man said. “But there’s an­other side to it, too.”

In re­cent years, pa­tient pref­er­ence in­for­ma­tion has been used to push ap­provals through the FDA’s path­way for high-risk de­vices, even in a case where the man­u­fac­turer failed to meet its own study goal.

In early 2015, the FDA ap­proved a first-of-a-kind obe­sity de­vice — an im­plantable stim­u­la­tor that shoots elec­tric­ity through the nerves con­nect­ing the stom­ach and brain. But less than a year ear­lier, the Mae­stro Recharge­able Sys­tem had re­ceived a mixed re­view from the agency’s sci­en­tists and out­side ad­vis­ers.

To demon­strate ef­fec­tive­ness, the FDA and the man­u­fac­turer agreed Mae­stro pa­tients would need to lose at least 10 per­cent more ex­cess body weight than pa­tients who re­ceived a sham treat­ment. But one-year data showed pa­tients with the de­vice lost only 8.5 per­cent more of their weight.

Left:

Above: A pa­tient re­ceives a tran­scra­nial mag­netic stim­u­la­tiontreat­ment at the VA Palo Alto Health Care Sys­tem on Wed­nes­day, Nov. 7, 2018, Palo Alto, Calif. The de­vice, which uses mag­neticfields to stim­u­late the brain, is be­ing used on mil­i­tary vet­er­ans suf­fer­ing from de­pres­sion. The FDA’s pre-mar­ket ap­provalprocess out­lined.

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