EU expert panel starts accepting applications to review high-risk IVDs

The incoming IVD regulation, set to go into effect next May, requires certain diagnostics be reviewed by the committee and/or tested by a reference lab.

By Nick Paul Taylor • Sept. 7, 2021

ECRI CEO: FDA, industry must revisit COVID-19 medical device EUAs as shortages ebb

Marcus Schabacker spoke to MedTech Dive about patient safety, cyberattacks in healthcare and risks from the rise of at-home care.

By Ricky Zipp • Sept. 3, 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

Medicare insolvency still expected by 2026, unchanged by COVID-19, trustees say

The forecast is a bit of a bright spot for the otherwise grim financial prospects of the program, as experts worried COVID-19 would result in the fund that finances Medicare Part A running out of money faster than previously expected.

By Rebecca Pifer • Sept. 3, 2021

FDA restarts distribution of Lilly’s COVID-19 drug in 22 states

Use of the treatment had been halted due to weakened efficacy versus an early coronavirus variant. Now, with delta widely prevalent and demand for antibody treatments surging, Lilly’s therapy will be available again. 

By Shoshana Dubnow • Aug. 31, 2021

Top FDA vaccine officials to leave agency as decision on COVID-19 boosters looms

Marion Gruber and Phil Krause, veteran vaccine reviewers, are unexpectedly departing at a critical time. The search for their replacements will begin “imminently,” division head Peter Marks said in a letter.

By Ben Fidler • Updated Aug. 31, 2021

Zimmer ‘smart knee’ gets FDA nod as ortho rivalry with Stryker heats up

The orthopaedics device maker, through a collaboration with Canary Medical, becomes the first company to bring an implantable smart device for total knee replacement to the U.S. market.

By Susan Kelly • Aug. 31, 2021

BD gets emergency FDA nod for smartphone-enabled COVID-19 test

The medtech is launching the product against a backdrop of rising demand for similar diagnostics, as the delta wave spurs a surge in cases nationwide after a pullback in the first part of the year.

By Nick Paul Taylor • Aug. 27, 2021

Medtechs made it out of Q2 with minimal impact from delta. That could change in Q3.

After procedure-dependent medtechs reported strong elective returns in the first half of 2021, the delta variant is now posing a risk to the industry’s recovery as hospitals once again shut down procedures.

By Ricky Zipp • Aug. 26, 2021

Diabetes screening advised to start at age 35 for overweight, obese people

New advice from the U.S. Preventive Services Task Force comes as diabetes tech companies look to expand further into the Type 2 population.

By Susan Kelly • Aug. 25, 2021

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

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

EU launches probe of Illumina decision to close Grail deal despite ongoing investigation

If the European Commission finds that Illumina breached a “standstill obligation” rule as part of this latest probe, the company could be fined up to 10% of its revenue.

By Nick Paul Taylor • Updated Aug. 20, 2021

Patients were still hesitant to seek medical care out of virus fears this spring, survey finds

Despite reopenings, one in 10 nonelderly adults put off needed medical care this spring, an April survey from the Urban Institute found.

By Hailey Mensik • Aug. 19, 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

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

Amid delta surge, Thermo Fisher EUA for COVID-19 assays seeks to compensate for variants

FDA in January said accuracy of PCR tests from Thermo Fisher and others may be affected by variants. Testing chief Tim Stenzel said the agency is working to ensure EUA-authorized tests are still performing amid virus mutations.

By Greg Slabodkin • Aug. 16, 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

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