FTC warns app makers fall under breach notification rule

The agency noted that developers of health apps and connected devices are considered healthcare providers. Any unauthorized access, including sharing information without consent, would trigger the Health Breach Notification Rule.

By Shannon Muchmore • Sept. 16, 2021

FDA creates new office to drive forward digital transformation strategy

Vid Desai, who will help lead the new Office of Digital Transformation, was also named as the agency's chief information officer. FDA is seeking an extra $75.9 million in the 2022 budget to support the modernization plan.

By Nick Paul Taylor • Sept. 16, 2021

Explore the Trendline➔

Medical device industry continues to turn to AI

While the industry continues to embrace artificial intelligence, there are still questions about how the new technologies need to be regulated and if they are effective.

By MedTech Dive staff

CMS moves to scrap MCIT rule due to clinical evidence concerns

AdvaMed said the repeal of the Medicare Coverage of Innovative Technology rule is the wrong decision for patients. Analysts wrote the breakthrough device pathway could be resurrected in Cures 2.0 legislation. 

By Nick Paul Taylor • Sept. 14, 2021

Medtechs are boosting DTC investment, but industry still years behind pharma

Companies are spending hundreds of millions of dollars every year on direct-to-consumer advertising as the industry focuses on marketing more to patients.

By Ricky Zipp • Sept. 14, 2021

MedTech Europe calls for urgent clarification of EU artificial intelligence proposal

The trade group worries "unnecessary overlaps" between the proposed AI Act and medical device regulations, such as MDR and IVDR, could affect access to products as well as lead to legal uncertainty.

By Nick Paul Taylor • Sept. 13, 2021

Abbott, Quest, Quidel likely to benefit from Biden's COVID-19 testing push

Using the Defense Production Act, the White House will push for expanded test production, with $2 billion earmarked to buy nearly 300 million rapid antigen tests for schools, health centers and food banks.  

By Greg Slabodkin • Sept. 10, 2021

FDA ends summer with fresh batch of breakthrough device designations

Novocure and CellMax Life are among the latest to get regulatory privileges for experimental devices used to treat and detect cancers.

By Nick Paul Taylor • Sept. 10, 2021

Spine devices, recalls and endovascular stents on FDA's fall meeting lineup

Other topics include Integra's bid for approval of a device used as soft tissue support in post-mastectomy breast reconstruction and a workshop on artificial intelligence and machine learning. 

By Nick Paul Taylor • Sept. 8, 2021

Feds sue UPMC heart surgeon for billing multiple surgeries at same time

The False Claims Act litigation also accuses the health system of ignoring or minimizing complaints by employees and staff.

By Ron Shinkman • Sept. 7, 2021

TransMedics wins FDA nod for donor heart preservation system

Approval for the device comes two months after an FDA advisory panel backed the company's liver preservation system and follows the go-ahead for its donor lung technology in 2019.

By Susan Kelly • Sept. 7, 2021

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

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