BD plans $540M sale of surgical instrumentation platform to Steris Becton Dickinson, one of the world’s largest medical technology companies, said in a statement Tuesday it has entered into a definitive agreement to sell its surgical instrumentation platform to Steris, an Ohio-based medical device firm specializing… Jun 20 23June 20, 2023Article at medtechdive.com
How they built it: Florian Hillen wants to look at your teeth with his AI Using artificial intelligence to examine dental X-rays can nearly double diagnostic accuracy, and help detect other diseases. Florian Hillen is a medical school dropout, artificial intelligence enthusiast, former MIT graduate student and Harvard… Jun 07 23June 07, 2023Article at medtechdive.com
Cue Health wins first non-emergency authorization for COVID test, days after Goldman downgrade The U.S. Food and Drug Administration has granted de novo clearance to the Cue COVID-19 Molecular Test, the first at-home, over-the-counter test for COVID-19 to use the traditional premarket review pathway.The authorization represents “a new era of… Jun 07 23June 07, 2023Article at medtechdive.com
Philips faces new recall of Evo respirators, tagged Class I by FDA Dive Brief: As many as 57,000 Evo ventilators are facing a voluntary recall by Philips over problems with the machines’ air flow sensor.The U.S. Food and Drug Administration has labeled the recall Class I, warning that filters must be changed… Jun 06 23June 06, 2023Article at medtechdive.com
Abiomed heart pump recall labeled Class I by FDA, no deaths reported The recall, tied to specific sets of the Impella 5.5 with SmartAssist, comes just months after Johnson & Johnson paid $16.6 billion for Abiomed The FDA said Monday that Abiomed, the heart device maker bought by Johnson & Johnson last year for $16.6… Jun 05 23June 05, 2023Article at medtechdive.com
Getinge will acquire High Purity for as much as $370M to bolster biopharma business The acquisition is aimed at strengthening Getinge’s position in the fast-growing area of custom single-use solutions for bioprocessing applications. Getinge, a Sweden-based maker of technology for hospital care, cardiovascular procedures and sterile… May 31 23May 31, 2023Article at medtechdive.com
Medtronic posts profit, sales growth in Q4, agrees to buy Korean diabetes patch maker The company is “confident in delivering durable revenue growth in the year ahead” amid continued improvements in procedure volumes. By the numbers Q4 Non-GAAP Net income: $2.1 billion Q4 Earnings per share (non-GAAP diluted): $1.57 FY2023 non-GAAP… May 25 23May 25, 2023Article at medtechdive.com
3M plans 6,000 layoffs as hospital staffing woes continue to curb procedures Manufacturing and supply chain “headwinds” hurt operating margins in the first quarter, the company said. By the numbers Q1 Healthcare adjusted operating income: $360 million Q1 Insights 3M, which makes wound care and dental products, said it will… Apr 27 23April 27, 2023Article at medtechdive.com
Thermo Fisher reports 9% drop in Q1 revenue, shares slip By the numbers Q1 Earnings per share (diluted): $3.32 Q1 Insights: Thermo Fisher Scientific, the world’s largest provider of scientific instruments and laboratory and diagnostic machines and materials, reported a 9% decline in first-quarter revenue… Apr 26 23April 26, 2023Article at medtechdive.com
LivaNova CEO quits as firm announces higher-than-expected preliminary earnings LivaNova, a UK-based medical device maker, announced late Friday that its CEO, Damien McDonald, has resigned. At the same time, it reported preliminary first-quarter earnings that beat the expectations of analysts. The firm’s chairman, William Kozy,… Apr 17 23April 17, 2023Article at medtechdive.com
Abbott faces Class I recall of 4.2M glucose readers on battery fire risks Readers for Abbott’s FreeStyle Libre glucose monitoring systems could catch fire if improperly stored or charged, FDA says. Abbott has initiated a recall for readers for its FreeStyle Libre glucose monitoring systems, which are at risk of catching… Apr 06 23April 06, 2023Article at medtechdive.com
Philips CEO Jakobs expects first settlement on respirators this year, Dutch newspaper says Jakobs said he “hopes and expects” to reach a settlement with the Food and Drug Administration this year; settling suits over alleged medical damages may take longer. Philips is pushing for a settlement this year of the first in a series of… Mar 31 23March 31, 2023Article at medtechdive.com
Silicon Valley Bank’s swift collapse appears to have left established medtech firms untouched The collapse last week of Silicon Valley Bank, a storied lender and financier of startups including some medtech companies, appears to have had a minimal effect on established firms in the sector, according to a survey by analysts at two banks that… Mar 13 23March 13, 2023Article at medtechdive.com
LivaNova receives FDA nod for heart-lung machine After beginning its European rollout last month, the UK-based device maker hopes to bring its market-leading position to the U.S. UK-based LivaNova said it received 510(k) clearance from the U.S. Food and Drug Administration for its Essenz Heart-Lung… Mar 10 23March 10, 2023Article at medtechdive.com
J&J loses bid for Supreme Court review of $302M vaginal-mesh verdict The court’s decision to let a lower court verdict stand leaves the company subject to varying state liability laws, J&J says. The move is a victory for California, the first state to go to trial against the company after thousands of U.S. women sued… Feb 21 23February 21, 2023Article at medtechdive.com
Medtech M&A outlook for 2023: Spinoffs, China exits, AI opportunities poised to spur deal rebound Companies flush with cash are looking for good investments and innovative products that can reduce procedure costs, industry observers say. Medtech companies hit the brakes on large mergers and acquisitions last year with 11 transactions valued above… Jan 31 23January 31, 2023Article at medtechdive.com
GE HealthCare posts revenue growth in last quarter before spinoff on imaging, ultrasound units The company benefitted from “robust end-market demand, improved pricing, and easing supply chain pressures” in the period. By the numbers GE HealthCare, reporting earnings for its last time as a subsidiary of General Electric, posted an 8% gain in… Jan 30 23January 30, 2023Article at medtechdive.com
Medtech regulation outlook in 2023: Faster approvals among priorities as AI moves to fore Leaders from across the medtech field weigh in on the prospects and challenges for product regulation in 2023. For medical device makers – and the patients who rely on them – 2023 is poised to be a year of challenge and change for regulation. A… Jan 26 23January 26, 2023Article at medtechdive.com
J&J sees Abiomed adding to revenue in 2024; Q4 sales drop By the numbers Johnson & Johnson, the second-biggest medtech firm after Medtronic, said on an earnings call Tuesday that it expects the $16.6 billion acquisition of heart assist device maker Abiomed to add to earnings in 2024 as it positions the… Jan 24 23January 24, 2023Article at medtechdive.com
3 questions for Michael Snyder, lead inventor of single-drop blood test The head of a Stanford research team says the test differs from Theranos’ defunct product because “ours works.” Michael Snyder is chairman of the Department of Genetics at Stanford University, where he is also the director of the Center for Genomics… Jan 23 23January 23, 2023Article at medtechdive.com