Medtronic's HeartWare HVAD ending brings questions about $1B acquisition

Nearly five years after Medtronic's buy of HeartWare International, the medtech giant pulled the flagship product of the deal due to safety risks, ceding the market to rival Abbott.

By Ricky Zipp • June 8, 2021

Medtronic lands FDA approval for brain stimulation leads it expects to drive share gains

CEO Geoff Martha has boasted the nod for SenSight will help it close "a key competitive gap." The medtech competes with Abbott and Boston Scientific in the market. 

By Nick Paul Taylor • June 8, 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

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 7, 2021

Dexcom shares clinical data on G7 CGM ahead of next-gen showdown with Abbott

The results compare favorably to data on Abbott’s Libre 2, further setting the stage for the release of one of the most anticipated new products of 2021 in the diabetes tech market.

By Nick Paul Taylor • June 4, 2021

Medtronic pulls HeartWare HVAD pump from market amid recalls, patient deaths

The medtech said the move was influenced by growing evidence the system had higher mortality risks than comparable devices. FDA advised providers to use Abbott's HeartMate 3 as an alternative.

By Ricky Zipp • June 3, 2021

FDA warns device makers of falsified records at Italian ethylene oxide sterilization facilities

BD and Medtronic are among those that already recalled products processed by Steril Milano, accused by the agency of falsifying graphs and parameters of sterilization certificates for a variety of products dating back to 2016.

By Nick Paul Taylor • June 3, 2021

Abiomed buys preCARDIA to bag breakthrough heart failure device

William Blair analysts had hopes the buy could help Abiomed move past "two years of commercial disruptions" to drive long-term growth.

By Nick Paul Taylor • June 2, 2021

Amid pricing tumult, iRhythm CEO resigns after 4 months in office

After taking over on Jan. 12, Mike Coyle stepped down Tuesday. CFO Douglas Devine will assume the role amid a search for a permanent replacement. Shares were down by nearly 17% Wednesday morning.

By Ricky Zipp • June 2, 2021

FDA seeks 8% budget boost for CDRH to back resurgence of domestic device production

The Biden administration said its request for the Center for Devices and Radiological Health will help the U.S. reduce reliance on products from China and other countries and strengthen its ability to respond to emergencies.

By Nick Paul Taylor • June 1, 2021

Swiss medtech sounds alarm as MDR erects barriers to EU market

The Swiss Medical Technology Association said the change will cost the industry it represents the equivalent of $126 million to meet new administrative requirements.

By Nick Paul Taylor • May 28, 2021

Medtronic steps up robotics bet as its challenger to Intuitive starts clinical trial

The medtech giant seeks to double or triple sales in its 2023 fiscal year. However, analysts warned that near-term investments will pressure margins in the short term.

By Nick Paul Taylor • May 28, 2021

Rising hospital ransomware attacks could endanger patients, hit bottom lines hard, Moody's says

Systems have been rendered more vulnerable due to COVID-19 as more non-clinical employees work from home. The warning echos comments made recently by the FDA's cyber chief for medical devices. 

By Ron Shinkman • May 27, 2021

Analysts tip Edwards' US TAVR growth at 90% in April

A Jefferies review of hospital data suggests the medtech could comfortably beat the current analyst growth forecast, but comes with multiple caveats.

By Nick Paul Taylor • May 27, 2021

Medtronic revenue up 37% as electives make a comeback

CEO Geoff Martha told investors Thursday most businesses are returning to near pre-COVID-19 growth rates, though he admitted there is "work to do" in areas like neurovascular and diabetes.

By Greg Slabodkin • May 27, 2021

FDA draft guidances lay out postmarket medical device data requirements

Building on existing policy, one proposal deals with rules for Class II and III products while another relates to PMAs. 

By Nick Paul Taylor • May 27, 2021

MDR challenges remain as regulation goes into effect: MedTech Europe

The European trade group contends that while the Medical Device Regulation's May 26 effective date marks a significant milestone, hurdles limit industry’s ability to "seamlessly supply certified devices under the new rules."  

By Greg Slabodkin • May 26, 2021

Senate confirms Chiquita Brooks-LaSure as head of CMS

AdvaMed and MDMA both called out the Medicare Coverage of Innovative Technology rule, now delayed, as a priority for the new administrator. President Joe Biden has yet to name an FDA chief.

By Rebecca Pifer • May 25, 2021

Ransomware, other cyber threats mount as medtech industry tries to adapt

"Everything is hackable," said Kevin Fu, the FDA's medical device cybersecurity chief, who noted that ransomware in particular can render a device useless. 

By Greg Slabodkin • May 25, 2021

FDA clears 2 endoscopes that avoid reprocessing

The agency, which has urged a shift to endoscopes with single-use parts or that are fully disposable, gave the OK to UroViu to market a single-use cytoscope and to China's EndoFresh for a disposable digestive endoscopy system.

By Susan Kelly • May 25, 2021

MDR is live. Here are 5 things to know on where the rule stands.

The device industry has resolved some near term pressures as the EU's delayed landmark regulation comes into effect, but challenges related to IVDR, Brexit and more remain.

By Nick Paul Taylor • May 25, 2021

Boston Scientific recalls venous stents because of migration risk

The medtech giant is recalling all Vici SDS and Vici RDS stent systems distributed over a 30-month period after receiving 17 complaints. The FDA categorized it as a Class I recall, its most serious designation.

By Nick Paul Taylor • May 24, 2021

Biden orders Software Bill of Materials to boost cybersecurity. AdvaMed wants uniform standards.

An executive order calls for an electronically readable way to provide an inventory of third-party components in devices. The medtech lobby backs the idea but says standardization is critical.  

By Greg Slabodkin • May 21, 2021

FDA seeks feedback on device ingredient labeling requirements

The agency held a public meeting late in 2019 debating adding more specific information on materials used in devices with long-term exposure such as breast implants and metal-on-metal hips.

By Nick Paul Taylor • May 21, 2021

Medtronic HeartWare system hit with slew of Class I recalls, device reports since 2012 PMA

The pump has a higher rate of malfunction reports than rivals, according to an ECRI analysis of the FDA's MAUDE database. But it's hard to draw conclusions from a disparate system of safety reporting.

By Ricky Zipp • May 21, 2021

FDA 'working around the clock' with COVID-19 workload, all reviews impacted: CDRH chief

Jeff Shuren said Wednesday the agency might miss some Medical Device User Fee Amendments performance goals for PMA applications and 510(k) submissions.

By Greg Slabodkin • May 20, 2021