BD's Pyxis medication dispenser gets fifth DHS cybersecurity alert in 5 years

The company said there are no known public exploits that specifically target a password vulnerability and that it's working to address the problem.

By Nick Paul Taylor • June 1, 2022

Recalled devices surged in first quarter, driven by BD connectors

A recall of 288 million Becton Dickinson connectors for catheter ports drove up the total number of recalled devices in the quarter. Mislabeling was the top reason for FDA alerts over the three-month period, a Sedgwick report found.

By Nick Paul Taylor • June 1, 2022

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Medical device safety in spotlight after high profile recalls

From Philips’ massive recall of respiratory devices to ongoing health risks with breast implants, medical devices tied to patient harm have put a focus on product safety.

By MedTech Dive staff

Boston Scientific would be 'good fit' for increasingly acquisitive J&J, analysts say

A limited portfolio overlap could make Boston Scientific a target should Johnson & Johnson's CEO seek a large medtech acquisition.

By Nick Paul Taylor • May 31, 2022

Abbott's Libre 3 glucose monitor gets FDA clearance as CGM market intensifies

The 14-day glucose sensor is smaller and thinner than its predecessor, and will give Abbott a head start on rival Dexcom’s newest continuous glucose monitor. 

By Nick Paul Taylor • May 31, 2022

Abbott's imaging catheter recall gets Class I label from FDA over vascular injury risks

The proximal markers in the Dragonfly OpStar Imaging Catheters can become loose and separate from the device while in use.

By Nick Paul Taylor • May 27, 2022

Medtronic expects supply chain issues to continue after 'catastrophic explosion' last quarter

The company expects revenue to be down 4.5% to 5.5% next quarter, assuming no near-term improvement in the supply chain.

By Elise Reuter • Updated May 27, 2022

Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover

Company executives said the additional cost savings emerged as they took a closer look at Hillrom’s real estate footprint.

By Nick Paul Taylor • May 26, 2022

Verily advances smartwatch toward Parkinson's clinical trial use after validating technology

The researchers concluded the wearable device could reduce the sample size needed to show the effect of a therapeutic intervention.

By Nick Paul Taylor • May 25, 2022

How a Dexcom-Insulet combination would shake up the diabetes treatment industry

Following a Bloomberg News report that Dexcom is in talks to buy Insulet, analysts say such a move would put competitors in a "tough spot."

By Ricky Zipp • May 25, 2022

Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts

Companies are coping with factors such as supply disruptions, staffing shortages, inflation and foreign-exchange hurdles, according to William Blair analysts.

By Nick Paul Taylor • May 24, 2022

Dexcom says it's not in acquisition talks

Bloomberg News reported last week that the company was seeking to buy Insulet.

By Ricky Zipp • Updated May 31, 2022

Appeals court sides with Intuitive over J&J in surgical device patent disputes

A successful appeal by Ethicon would have affected imports of Intuitive Surgical’s SureForm staplers and associated reload cartridges.

By Nick Paul Taylor • May 24, 2022

AI and RWD in HCP engagement – here's the secret to effective execution

Rethink your approach to AI and RWD and turn ideas into actionable strategies for medtech marketers.

May 23, 2022

Edwards posts 97% success rate with tricuspid device in 30-day test as it prepares for Abbott rival

Edwards' device posted a 97% implant success rate, while Abbott's had a 98% success rate. Both are part of a growing market for transcatheter valve repair devices. 

By Nick Paul Taylor • May 20, 2022

FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown

The medical device reports were made between April 2021 and April 2022. Both Philips and the FDA contend that the reporting system has limitations, including the underreporting of events and inaccuracies of reports.

By Ricky Zipp • May 20, 2022

FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

By Elise Reuter • May 19, 2022

Study shows that Abbott's Amulet, Boston Scientific's Watchman devices are riskier for women

The analysis builds on previous studies showing that left atrial appendage occlusion devices are riskier for women. However, Abbott's recent study shows comparable outcomes for men and women at 18 months.

By Nick Paul Taylor • May 19, 2022

Medtronic links renal denervation to increased time below blood-pressure threshold

Results from two studies come after the medtech company had a setback in renal denervation in October. Medtronic is expected to report results from its pivotal trial this year.

By Nick Paul Taylor • May 18, 2022

Pear more than doubles revenue from last quarter, shares new economic data

The company is keeping its 2022 revenue forecast of $22 million. Pear also presented economic data, which analysts said would be important in conversations with payers.

By Elise Reuter • May 17, 2022

Avanos Medical recall gets Class I label from FDA following patient injury, death reports

The company reported in a recall notice that there have been 60 injuries and 23 patient deaths associated with the Avanos Medical Cortrak 2 Enteral Access System since 2015, according to the FDA.

By Ricky Zipp • May 17, 2022

Earnings week 4: Vicarious expects 2024 FDA filing for surgical robot; Steris reports record backlogs

Vicarious Surgical reaffirmed that it would not be making an FDA submission for its surgical robot until 2024, while Globus Medical and Steris discussed rising procedure volumes.

By Elise Reuter • May 16, 2022

Dexcom, Insulet, Tandem start 2022 with revenue growth after weathering omicron surge

All three diabetes technology companies reported that omicron pressured business in January before easing as the quarter progressed.

By Ricky Zipp • May 13, 2022

House subcommittee debates device remanufacturing definition, sends user-fees bill to next stage

Members of the House Subcommittee on Health passed the user-fees bill by a vote of 30-0 Wednesday, sending the legislation to the full House Committee on Energy and Commerce.

By Elise Reuter • May 12, 2022

Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

By Elise Reuter • Updated May 19, 2022

Medtronic completes Intersect acquisition following FTC order

The Federal Trade Commission required Medtronic to divest a subsidiary of Intersect ENT to complete the deal. Medtronic announced the $1.1 billion acquisition last August.

By Nick Paul Taylor • Updated May 16, 2022