Device maker to pay $15M to resolve false claims allegations, 'silent recall'

ACell failed to report a product recall to FDA and billed Medicare for indications sales reps knew were not backed by clinical data to receive inflated reimbursement, the Department of Justice said.

By David Lim • June 12, 2019

China leads world in digital health adoption, Philips survey finds

Healthcare professionals in China are more likely to recommend patients use digital health technologies than their peers in the West.

By Nick Paul Taylor • June 12, 2019

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

Germany, Ireland push EU to assess device regs preparedness

The delegations think a significant reduction in notified bodies is likely but hope to avoid delaying implementation "unless absolutely necessary."

By Nick Paul Taylor • June 12, 2019

Beta Bionics, Insulet seek shake-up of insulin delivery market at ADA

Data presented at the American Diabetes Association meeting move the companies a step closer to challenging Medtronic and Tandem.

By Nick Paul Taylor • June 11, 2019

Stimulation device for IBS pain in children gains De Novo clearance

The non-invasive nerve stimulator is placed behind the patient’s ear to send electrical pulses to cranial nerve bundles.

By Susan Kelly • June 10, 2019

Medtech avoids tariff blow as US, Mexico reach deal

President Donald Trump late Friday called off plans for a 5% tariff set to go into effect today on imports from Mexico.

By Susan Kelly • June 10, 2019

Device interoperability, CGM for Type 2 patients among ADA 2019 standouts

More options for automated insulin dosing systems are emerging, particularly as FDA established new device classifications for interoperable pumps and glycemic controller algorithms via the De Novo pathway.

By Maria Rachal • June 10, 2019

Harvard's Wyss Institute receives $131M gift

The contribution comes from founder Hansjörg Wyss, the former CEO of Swiss device maker Synthes, whose vision for the institute has led to several medical breakthroughs over the past decade.

By Susan Kelly • June 10, 2019

Abbott and Tandem in the spotlight at diabetes meeting

Abbott is sharing details of its FreeStyle Libre 2 CGM system, and Tandem is presenting data on its automated insulin delivery system.

By Nick Paul Taylor • June 7, 2019

Inside Quest Diagnostics, LabCorp's supply chain breach

The intrusion happened inside the American Medical Collection Agency, but responsibility is shared through its partner ecosystem.

By Samantha Schwartz • June 6, 2019

Executives expect AI to transform healthcare within 3 years

Almost 90% of industry leaders are trying AI and other emerging technologies, and high percentages also believe health IT can help them identify unmet consumer needs, according to a report from Accenture.

By Nick Paul Taylor • June 6, 2019

After Varian deal, New York opens 1st proton therapy center

The East Harlem-based treatment facility struck a 10-year, $115 million service agreement with Varian Medical Systems for its ProBeam equipment in 2015.

By Nick Paul Taylor • June 6, 2019

FDA approves DT MedTech's total ankle replacement implant

The company will aim to compete with Stryker and Zimmer Biomet.

By Nick Paul Taylor • June 6, 2019

Apple Watch, mesh slings among new NESTcc projects

The real-world evidence hub selected 12 new test cases to evaluate its model in medical device regulatory and clinical decision-making. 

By Susan Kelly • June 5, 2019

House committee passes 6% increase in FDA funding

The committee wants one FDA priority, the Transform Medical Device Safety, Cybersecurity, Review, and Innovation initiative, to make do with the same level of funding as it received in fiscal 2019.

By Nick Paul Taylor • June 5, 2019

Device industry praises FDA AI/ML framework, asks for Class III software inclusion

AdvaMed and the Combination Products Coalition applauded the agency's work on a regulatory approach for the emerging technology, but gave a slew of recommendations for FDA to consider as it develops a potential draft guidance.

By David Lim • June 4, 2019

Donor lung preservation system gains expanded indication

The approval allows TransMedics' lung preservation technology to be used for donor lungs initially deemed unacceptable for transplant due to the limitations of traditional cold storage.

By Susan Kelly • June 4, 2019

OIG issues alert on genetic testing scam

Scammers are trying to get personal information from Medicare beneficiaries by offering genetic testing through telemarketing calls, booths at public events, health fairs and door-to-door visits.

By Susan Kelly • June 4, 2019

UK regulators discourage use of paclitaxel devices to treat intermittent claudication

The notice is the latest signal of caution surrounding paclitaxel-eluting stents and coated balloons, coming two weeks before FDA is set to scrutinize the class of devices in a two-day meeting.

By Maria Rachal • June 4, 2019

EMA posts draft guidance on drug-device combinations

The European Medicines Agency published the text to inform companies of their obligations under the regulations set to come into force across the continent next year.

By Nick Paul Taylor • June 4, 2019

Multi-cancer blood test shows early promise at ASCO

Grail, with backers including Amazon, Bill Gates, Alphabet venture arm GV, J&J and Celgene, said it would move forward with testing based on positive early data presented in a poster at the cancer meeting.

By Susan Kelly • June 3, 2019

Device makers could feel pinch from Mexico tariffs

Medtech companies with manufacturing facilities in Mexico include Intuitive Surgical, Medtronic, Stryker and Teleflex, according to analysts.

By Susan Kelly • June 3, 2019

Roche, GE Healthcare partner on software for tumor boards

The companies expect that combining patient images and data in one location will help cancer teams decide on diagnosis and treatment plans more quickly and efficiently.

By Susan Kelly • June 3, 2019

FDA, industry, advisers say surgical staplers warrant premarket review

Medtronic's Covidien and Johnson & Johnson's Ethicon supply the staplers commonly used in minimally invasive surgeries. The devices will almost certainly be moved to Class II, but special controls are not yet finalized.

By Maria Rachal • May 31, 2019

FDA consults surgical device experts on down-classing certain hemostatic agents

Johnson & Johnson's Ethicon opposes loosening premarket requirements for the devices, maintaining strict controls are needed to ensure patient safety.

By Maria Rachal • May 31, 2019