Friday Q&A: Francine Kaufman, Senseonics’ CMO, talks growing users, a 365-day CGM, doctor recruitment

Kaufman spoke about Senseonics’ release of its 180-day CGM in the U.S., developing a unique product in the diabetes technology market and competing with Dexcom and Abbott.

By Ricky Zipp • Aug. 12, 2022

‘Underfunded’ FDA falls short in ensuring medical devices protect against cyberattacks, experts say

Medical device manufacturers argue the agency’s current rules on cybersecurity requirements are too restrictive and should be phased in gradually.

By Elise Reuter • Aug. 11, 2022

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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

Insulet raises forecast as Omnipod 5 sales climb; Tandem expects tougher market in second half

Both insulin pump companies grew revenue by more than 10% in the second quarter, but Tandem lowered its 2022 forecast amid a tougher market, while Insulet increased its guidance.

By Ricky Zipp • Aug. 11, 2022

Medtronic issues Class I recall of implantable cardioverter defibrillators in U.S.

The devices may deliver a reduced shock during high-voltage therapy, about 79% of the programmed energy.

By Nick Paul Taylor • Aug. 11, 2022

Roundup: Medical device industry confident it can ride out recession, wary of slowing capital sales

While companies may weather a recession, they still face challenges like hospital staffing shortages, supply chain disruption and inflation, RBC Capital Markets analysts wrote.

By Nick Paul Taylor • Updated Aug. 10, 2022

Boston Scientific says it’s investigating allegations of anti-bribery law violations

The company says the issue is centered on its operations in Vietnam.

By Nick Paul Taylor • Aug. 10, 2022

Eargo’s Q2 revenue slides amid decline in hearing-aid shipments

The company’s gross system shipments fell by more than 8,000 when compared to the year-earlier period.

By Ricky Zipp • Aug. 9, 2022

FDA’s hearing-aid guidance clears regulatory review amid push by lawmakers for OTC sales

The move comes after the agency proposed the creation of a new category of over-the-counter hearing aids in October.

By Nick Paul Taylor • Aug. 9, 2022

BD begins tender offers for up to $500M in debt to advance repayment strategy

The spinoff of the diabetes business to form Embecta has provided proceeds that BD plans to use to pay down $1 billion in debt, according to Fitch Ratings. 

By Nick Paul Taylor • Aug. 9, 2022

Senate passes $740B bill to lower healthcare costs after months of wrangling

While Republicans successfully challenged a planned $35 insulin price ceiling for patients on private insurance, the law still has implications for makers of diabetes devices.

By Nick Paul Taylor • Aug. 8, 2022

FDA’s breakthrough device designations poised for another record year

At the midpoint of the year, the FDA had granted 129 designations, suggesting it will break the previous full-year record of 206.

By Nick Paul Taylor • Aug. 8, 2022

Friday Q&A: FDA’s former medical device cybersecurity director says more investment needed in staffing

The FDA and medtech companies will need more cybersecurity staff to stay ahead of hackers, says Kevin Fu, who is now focused on building that workforce for the government, private sector and academia.

By Elise Reuter • Aug. 5, 2022

iRhythm raises 2022 revenue forecast after record number of registrations in Q2

The cardiac monitor maker increased the low end of its forecast by $5 million, although executives expect a flat third quarter compared to the second quarter due to macroeconomic pressures.

By Ricky Zipp • Aug. 5, 2022

SEC accuses surgical implant business of pulling forward sales to hit targets

According to the SEC, Surgalign, known at the time as RTI Surgical, shipped future orders ahead of schedule to pull forward revenues and mask disappointing sales figures.

By Nick Paul Taylor • Aug. 5, 2022

Hospitals have low level of accountability for connected device breaches

Of the 43% of organizations that reported a data breach in the past two years, 88% said at least one connected device was a contributing factor to the breach, according to a new report.

By Rebecca Pifer • Aug. 4, 2022

EPA names BD, Edwards and Medtronic on list of higher-risk sterilization facilities

AdvaMed said ethylene oxide is vital for prevention of serious infections and shutting facilities could disrupt the supply of medical devices.

By Nick Paul Taylor • Updated Aug. 5, 2022

BD’s base business growth in Q3 offset by drop in COVID-19 testing

The company reported a year-over-year drop of about $224 million in COVID-19 testing revenue compared to 2021, with the testing slowdown expected to continue. 

By Ricky Zipp • Aug. 4, 2022

Virtual Incision opens new frontier for robotic surgery with space station mission

Using a grant from NASA, the company will perform a mission on the International Space Station to show its platform’s suitability for long-duration space travel.

By Nick Paul Taylor • Aug. 3, 2022

Zimmer Biomet raises revenue forecast on faster-than-expected COVID recovery

The company saw sales across knee and hip procedures increase, though it still faces foreign currency and supply chain challenges.

By Elise Reuter • Aug. 2, 2022

Boston Scientific pays $85M to settle long-running patent dispute with Nevro

J.P. Morgan analysts said the settlement over spinal cord stimulation devices is “a dollar win for Nevro, but a longer-term competitive loss.”

By Nick Paul Taylor • Aug. 2, 2022

Insulet moves to full launch of Omnipod 5

BTIG analysts said the shift reflects success with user experience and logistics during a limited market release.

By Elise Reuter • Aug. 1, 2022

FDA extends Class I UDI submission deadline, exempts consumer health devices from requirements

The deadline extension should help manufacturers submit device identification data to an agency database, while freeing over-the-counter consumer devices from needless regulation.

By Nick Paul Taylor • Aug. 1, 2022

Edwards TAVR unit weighed down by hospital staffing shortages

CEO Mike Mussallem warns there "are going to be some casualties" if surgeries continue to be stalled.

By Elise Reuter • July 29, 2022

Dexcom’s G7 glucose monitor delayed until late 2022; stock price drops 5.6%

The CGM maker needs to update software for the product, pushing back the FDA’s decision and eventual U.S. release.

By Ricky Zipp • July 29, 2022

Friday Q&A: Eargo CEO Christian Gormsen talks OTC rule, challenging market leaders, DOJ settlement

New FDA regulations expected soon would boost firms like Eargo, allowing millions of Americans without hearing aids to buy them for less and without a prescription.

By Ricky Zipp • July 29, 2022