EU builds out MDR, IVDR guidance ahead of flurry of implementing acts

The European Commission has advice on notified bodies, quality management systems and COVID-19 tests, among other topics, as medtechs work to comply with the new and looming regulations.

By Nick Paul Taylor • Aug. 24, 2021

Robotic mastectomy's safety and effectiveness unproven, FDA warns

The agency doesn't call out specific firms. Intuitive Surgical is studying its da Vinci Xi system in prophylactic nipple-sparing mastectomy procedures, but tells MedTech Dive it has the required approval.

By Susan Kelly • Updated Aug. 23, 2021

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New medical devices are reshaping the medtech industry

From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.

By MedTech Dive staff

Remote collaboration from the operating room: The 'new normal' for medtech

For too long, medical information sharing and collaboration has depended on in-person communication. The COVID-19 pandemic has caused us to rethink how we deliver healthcare.

By Jerry Carter, Avail Medsystems • Aug. 23, 2021

Post call: How a pandemic transformed healthcare for the future

From the frontlines of 2020 to the forefront of the future, what worked, what didn’t, and what must be prioritized today to thrive tomorrow. 

Aug. 23, 2021

J&J chief Alex Gorsky to step down early next year

Citing family health reasons, Gorsky will transition to the role of executive chairman and pass his torch to Joaquin Duato, currently vice chairman of J&J's executive committee.

By Jacob Bell • Aug. 20, 2021

Biden said to rule out Woodcock as permanent FDA chief

A published report indicated the agency's longtime drug reviewer is no longer in consideration for the role, leaving it unfilled seven months into President Joe Biden's term.

By Jonathan Gardner • Aug. 20, 2021

TAVR sites concentrated in urban areas linked to mortality risk, study finds

Mayo Clinic cardiologists used the findings to call for CMS to withhold reimbursement from sites that fail to meet its original selection or quality criteria.

By Nick Paul Taylor • Aug. 20, 2021

Abiomed leads latest FDA breakthrough designations for heart disease devices

The agency awarded the breakthrough privileges to Abiomed's Impella ECP, which the company contends is the world's smallest heart pump and could provide critical hemodynamic support to coronary artery disease patients.

By Nick Paul Taylor • Aug. 19, 2021

FDA warns of BlackBerry cyber vulnerability in medical devices

The operating system is often deployed in devices such as cardiac and patient monitors, drug infusion pumps, imaging and surgical robots, according to Nick Yuran, CEO of security consultancy Harbor Labs.

By Greg Slabodkin • Aug. 18, 2021

Zimmer's Rosa total hip system gets FDA nod, fueling robotics rivalry

The clearance allows the medtech to keep pace with Stryker's Mako line. However, delta variant surges could limit procedure volumes in the second half.

By Ricky Zipp • Aug. 18, 2021

Industry pitches FDA with 26% rise in user fee funding in MDUFA V negotiations

The offer tops $1.2 billion but represents a sharp slowdown in the rate of user fee hikes seen in earlier iterations of MDUFA. AdvaMed declined to comment.

By Nick Paul Taylor • Aug. 18, 2021

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

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 Parduhn • 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