Intuitive's da Vinci placements dropped in Q2 due to 'choppy' supply chain, tighter spending by hospitals

CEO Gary Guthart said the larger economic trends that pressured the company in the second quarter are poised to continue.

By Ricky Zipp • July 22, 2022

Smiths Medical's recall of syringe infusion pumps labeled Class I event after injuries, death

The company is asking customers to return devices if abnormal circuit board behavior causes the pump to stop.

By Nick Paul Taylor • July 21, 2022

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

AbbVie agrees to pay $60M for rights to acquire implantable glaucoma device

The biotech company said the deal is an opportunity to grow its eye-care business.

By Elise Reuter • July 20, 2022

FDA patient advisers grapple with consent, oversight of virtual-reality devices in healthcare

The advisory group addressed patient consent in surgeries using augmented reality tools and how to distinguish clinical uses of virtual reality from entertainment products. 

By Elise Reuter • July 20, 2022

Abbott's Q2 sales boosted by COVID-19 testing; outlook for diagnostics demand remains uncertain

The company’s $2.3 billion in COVID-19 testing sales beat J.P. Morgan and Stifel analysts’ estimates by about $1 billion, while CEO Robert Ford cautioned that forecasting demand remains challenging.

By Ricky Zipp • July 20, 2022

Defibrillators, chest drains added to FDA's list of device shortages

The defibrillator supply disruption reflects both increased demand and problems sourcing a component, part or accessory.

By Nick Paul Taylor • July 20, 2022

J&J lowers full-year sales forecast amid rising inflation, currency pressures

Despite foreign-exchange pressures, analysts said the results were an “encouraging starting point” as medtech companies begin reporting their quarterly earnings.

By Elise Reuter • July 19, 2022

iRhythm says Q2 unit volumes beat forecast, names Chad Patterson as new CCO

The company noted the results are preliminary and may change before its Aug. 4 earnings call.

By Ricky Zipp • July 19, 2022

Hologic's stock rating cut by BTIG amid worsening supply chain challenges, drop in COVID testing

The company is facing challenges including increasing operating expenses and shortages of semiconductor chips, according to the analyst report.

By Ricky Zipp • July 18, 2022

Notified bodies have yet to issue MDR certificates for 85% of legacy devices: survey

The EU's Medical Device Regulation certification process is taking twice as long as the old directive pathway and smaller companies are struggling to get started, the poll shows.

By Nick Paul Taylor • July 18, 2022

FDA faces furloughs if Senate misses August deadline for user fee bill

If legislation isn’t passed before the August recess, the FDA would have to furlough workers, slowing its review of medical device and pharmaceutical products. 

By Elise Reuter • July 15, 2022

Medtronic warns European healthcare providers of safety problem in defibrillators

The warning adds to Medtronic’s growing list of product safety issues over the last 18 months.

By Ricky Zipp • July 15, 2022

Abbott, Intuitive, J&J to kick off quarterly earnings season next week as recession threat looms

Earnings results are poised to set expectations for the impact of a potential slowdown and shed light on trends with implications for companies including Boston Scientific, Medtronic and Stryker.

By Nick Paul Taylor • July 15, 2022

With medtech shares down 30%, investors worry about inflation, staffing shortages: William Blair

Data suggests earlier pessimism about the sector could drive stocks to outperform major indices later this year.

By Elise Reuter • July 14, 2022

Rising procedure volumes boost hopes for Abbott, J&J as orthopedics lag, survey finds

Stifel analysts see the findings as positive for Abbott, J&J and Intuitive and supportive of Edwards and Medtronic’s TAVR targets. The survey comes just before the medtech industry reports its latest earnings.

By Nick Paul Taylor • July 14, 2022

Abbott gets FDA breakthrough tag for deep brain stimulation system in depression

The breakthrough device designation builds on a series of clinical trials of other systems that have yielded mixed results.

By Nick Paul Taylor • July 13, 2022

Medtronic lands option to buy artery disease player CathWorks for up to $585M

CathWorks has the right to compel Medtronic to complete the acquisition if it chooses not to exercise its option.

By Nick Paul Taylor • July 13, 2022

Faulty oximeter readings led to racial, ethnic disparities in treatment: study

Researchers previously noted that the devices may be less accurate when used by people with darker skin, and a recent study found the difference led to patients failing to receive needed treatment.

By Elise Reuter • July 12, 2022

CMS makes 'market-moving proposals' to some medtech Medicare rates, say analysts

BTIG analysts warned in a recent report that the changes “might curtail usage of some higher-dollar” medical devices.

By Nick Paul Taylor • July 12, 2022

European Commission targets spring of 2024 for fully functional Eudamed database

The Commission is planning a two-phase transition to mandatory use of the database after it goes live.

By Nick Paul Taylor • July 11, 2022

Medtronic recalls over 1M dialysis catheters due to malfunction

The recall is the latest in a growing list of product safety issues for Medtronic, including Class I recalls and an FDA warning letter for its diabetes unit.

By Ricky Zipp • July 11, 2022

Ex-Mazor executive charged by SEC with insider trading over Medtronic's $1.6B buyout

Doron Tavlin, who was Mazor’s vice president of business development, is accused by the agency of profiting from his inside knowledge of the pending takeover.

By Nick Paul Taylor • July 11, 2022

Friday Q&A: Roy Jakobs, Philips' head of connected care, talks sleep apnea recall, changing safety protocols

In the midst of a recall of 5.5 million sleep apnea devices and ventilators, Jakobs spoke about the company's recall process, communication efforts, and how the repair and replacement program is progressing.

By Ricky Zipp • July 8, 2022

CMS proposes national rates for cardiac monitoring; iRhythm's stock jumps

The proposed rule could end a years-long saga for the cardiac market, although pricing specifics may change in the final version.

By Ricky Zipp • July 8, 2022

Semiconductor shortage leaves medtech industry 'more pessimistic' as customers leave, says Deloitte

Hospitals and health systems are looking into alternative products as a result of the disruption, according to a report from Deloitte and AdvaMed.

By Nick Paul Taylor • July 7, 2022