FDA seeks more power for medical device cybersecurity mandates

CDRH wants to require medtechs to have a Software Bill of Materials ready upfront as part of a premarket submission, as well as the capability to update and patch device security into a product's design.

By Greg Slabodkin • Aug. 17, 2021

Boston Scientific's vaginal mesh studies entrench FDA's view that risks outweigh benefits

After halting sales of the product in 2019, the regulator said the additional risks associated with transvaginal mesh repair mean it "continues to believe that these devices do not have a favorable benefit-risk profile."

By Nick Paul Taylor • Aug. 17, 2021

Explore the Trendline➔

Top 5 stories from MedTech Dive

From haphazard layoffs at the Food and Drug Administration to the industry’s current IPO environment and tracking FDA-authorized AI devices, here is a collection of top stories from MedTech Dive.

By MedTech Dive staff

Abbott's Amulet FDA approval sets stage for US market fight with Boston Scientific

The atrial fibrillation device will challenge Boston Scientific's Watchman in a market valued at $500 million. Abbott plans to release a head-to-head study with its rival at the end of the month.

By Ricky Zipp • Aug. 16, 2021

Memic inks SPAC merger, lining up $360M to challenge Intuitive for robotic surgery market

The company is betting the small size of its device and potential to enable more hysterectomies to be done vaginally as differentiators that will enable it to grow sales to $136 million in 2025.

By Nick Paul Taylor • Aug. 16, 2021

Medtechs need to up their cybersecurity threat modeling game, FDA says

The agency "will be looking for much more detailed and comprehensive" cyber threat models as part of premarket review, said Suzanne Schwartz, director of CDRH's Office of Strategic Partnerships and Technology Innovation.  

By Greg Slabodkin • Aug. 13, 2021

US now a priority market for most developers of novel devices, FDA survey finds

CDRH topped its goal to boost the percentage of manufacturers that target the U.S. market at least at the same time as rival regions.

By Nick Paul Taylor • Aug. 13, 2021

NESTcc seeks feedback on active postmarket medical device surveillance system

The National Evaluation System for health Technology plans to work with a contractor to test real world scenarios for devices such as ventilators, robotic surgery, breast implants and fully disposable duodenoscopes.

By Nick Paul Taylor • Aug. 13, 2021

Medtech industry starts to face lack of diversity, execs of color

AdvaMed contends the percentage of Black people in leadership roles at device companies has more than doubled from 1.3% to 3.2% since 2015. However, currently none of the largest medtechs has a CEO of color.

By Greg Slabodkin • Aug. 12, 2021

Study reveals stroke risk that brought down Medtronic's HeartWare HVAD

Registry data shows that the pump had a higher rate of stroke than Abbott's HeartMate 3. The study comes weeks after Medtronic pulled the device from the market in response to neurological adverse events. 

By Nick Paul Taylor • Aug. 12, 2021

Should healthcare organizations pay to settle a ransomware attack? Experts weigh in at HIMSS21

"I don't think there's a single yes or no," said Michael Coates, former chief information security officer for Twitter.

By Rebecca Pifer • Aug. 11, 2021

Boston Scientific gets FDA nod for single-use bronchoscope, sees $2B opportunity

The medtech giant is targeting a potentially lucrative market but will face competition from rivals with a longer history in the space, including Ambu and Olympus. A limited U.S. release of the device is set for the coming weeks. 

By Nick Paul Taylor • Aug. 11, 2021

'Evidence gaps' spur CMS to call meeting to discuss cerebrovascular devices

The agency said the "shorter term data with greater reliance upon intermediate and surrogate outcomes" used to bring devices to market is "generally less helpful" for its assessments.

By Nick Paul Taylor • Aug. 11, 2021

Philip Morris buys developer of inhaled heart attack drug, ramping up push into healthcare

News of the takeover comes weeks after the tobacco company bought an oral drug delivery specialist and entered into a bidding war to buy inhaled medicine player Vectura. Health charities have pushed back against Philip Morris' foray.

By Nick Paul Taylor • Aug. 10, 2021

Diabetes tech companies set sights on Type 2 patients as user numbers climb

With patients flocking to CGMs and insulin pumps over the past several years, companies like Dexcom, Insulet and Tandem are looking to further expand. 

By Ricky Zipp • Aug. 9, 2021

New digital health solution helps mass COVID-19 testing to prevent Delta variant resurgence

To sustain reopened activities, identify outbreaks and new variants, the ability to manage testing at pace and scale has never been more urgent.

By Piers Ford • Aug. 9, 2021

FDA puts Class I label on Boston Scientific recall estimated to affect one-third of pacemaker line

The medtech giant took the action after discovering devices, once hailed as a growth driver, can incorrectly enter safety mode, putting patients at risk of serious injury.

By Nick Paul Taylor • Aug. 9, 2021

Medtronic to buy Intersect ENT in $1.1B deal targeting chronic rhinosinusitis market

Intersect ENT's implants, which deliver steroids to open sinus passageways, could position Medtronic to sell products for a condition affecting 35 million U.S. adults. 

By Greg Slabodkin • Aug. 6, 2021

ResMed reaffirms Philips recall is up to $350M boost but held back by supply chain struggles

"Supply bottlenecks continue to restrict our access to critical electronic components, especially semiconductor chips, that ultimately limit our net production output,” CEO Mick Farrell told investors late Thursday.

By Nick Paul Taylor • Updated Oct. 29, 2021

iRhythm doesn't expect 2022 CMS pricing. 'It may take some time.'

Amid a challenging 2021, the cardiac monitoring player beat Wall Street revenue expectations. However, Medicare pricing uncertainty is still hanging over its future.

By Ricky Zipp • Aug. 6, 2021

BD results called mixed amid bullish COVID-19 testing outlook

The medtech assumes no major system-wide hospital restrictions on electives, despite the rapid spread of the delta variant, raising eyebrows from one analyst group. BD also announced CFO Chris Reidy will retire.

By Greg Slabodkin • Aug. 5, 2021

Nevro shares plunge 25% after sluggish Q2, execs brace for worse to come

Struggles in the second quarter led analysts to question whether the company is losing share to rivals such as Abbott Laboratories, Boston Scientific and Medtronic. Nevro refuted the idea that it's losing market share.

By Nick Paul Taylor • Aug. 5, 2021

Outpatient revenue drives hospital volume rebound in June, Kaufman Hall says

The report's year-to-date trends in outpatient visit growth add to color from medtech companies reporting electives rebounding in recent financial results.

By Hailey Mensik • Aug. 4, 2021

Rival to Boston Scientific's Sentinel meets skeptics at FDA advisory panel

One expert said there's "compelling evidence that [Keystone Heart] not only didn't demonstrate efficacy, but there's a potential signal of harm."

By Nick Paul Taylor • Aug. 4, 2021

Philips ventilator recall labeled Class I by FDA, second in as many weeks

The recall was triggered by identification of a risk that ventilators will provide lower oxygen flow. The Class I event is separate from FDA's designation in July of a recall impacting millions of Philips sleep apnea and ventilator devices.

By Nick Paul Taylor • Aug. 4, 2021

Roundup: Medtechs mirror pre-pandemic results in Q2 fueled by procedure volume recovery

After elective procedures began gradually rebounding in the first quarter of 2021, companies are reporting results close to or beating 2019 levels.

Aug. 3, 2021