Medtronic stock is taking a hit after an FDA review panel found the risks of its renal denervation system outweighed the benefits. The world’s largest medical device company engaged in more than a decade of clinical trials and research — with multiple disappointments along the way — as it made a bet that its radiofrequency-energy-based […]
ReCor Medical wins FDA panel nod for its renal denervation system
ReCor Medical announced that an FDA panel has voted in favor of the safety and efficacy of its Paradise ultrasound renal denervation (RDN) system for treating hypertension. On Aug. 22, the Circulatory Systems Devices Panel of the FDA’s Medical Devices Advisory Committee voted 12–0 in favor with regard to safety and 8–3 in favor, with […]
Integra Lifesciences hit with FDA warning letter over Boston facility
The FDA says Integra Lifesciences has inadequately responded to violations that it found at the company’s TEI Biosciences plant in Boston. Integra Lifesciences’ Boston facility makes extracellular bovine matrix products for tissue repair and regeneration, wound care and more. In May, the company voluntarily recalled all tissue-related products made in Boston and distributed between March 1, […]
Zimmer Biomet CEO leaves to take over another big medtech
Bryan Hanson has left the corner office of ortho tech giant Zimmer Biomet to become CEO of the soon-to-be-independent healthcare business at 3M, the companies announced today. Hanson takes over 3M’s healthcare business on Sept. 1. “I have a deep respect and admiration for what 3M has built in health care — strong brands, quality […]
The 10 largest orthopedic device companies in the world
Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year. Stryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic. GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 […]
Philips Respironics has a Class I level ventilators recall
The FDA has posted information on its website about another serious recall involving Philips Respironics products. The news comes the same week that Philips got a vote of confidence from Exor, the investment arm of Italy’s wealthy Agnelli family, which bought a 15% stake in the Dutch medtech giant to become its largest shareholder. Media […]
Illumina says SEC is investigating Grail acquisition
Add a U.S. Securities and Exchange Commission investigation to the list of problems that Illumina has faced since it acquired Grail for $8 billion in 2021. Illumina disclosed the investigation in its 10-Q filed with the SEC on Aug. 10: “In July 2023, we were informed that the staff of the SEC was conducting an […]
Orthofix beats The Street in Q2, upping full-year guidance
Orthofix Medical posted second-quarter results this evening that beat the consensus forecast on Wall Street. It also raised its revenue and adjusted EBITDA guidance for the rest of the year, reflecting positive developments in Bone Growth Therapies and other sectors. It’s been more than eight months since Orthofix’s merger with SeaSpine. The Lewisville, Texas–based orthopedic […]
Globus Medical beats The Street in Q2 as it prepares for spine tech merger
Globus Medical (NYSE: GMED) reported second-quarter results that beat analyst expectations, upping its full-year sales guidance as it prepares to merge with NuVasive. The news yesterday evening came a day after NuVasive reported mixed results heading into the merger, which would create the world’s second-largest spine tech company after Medtronic. The CEOs of both Globus Medical […]
Stryker surpasses Q2 forecasts, boosts full-year outlook
Stryker this evening reported second-quarter results that beat the Wall Street consensus forecast, prompting it to up its full-year guidance. The Kalamazoo, Michigan–based orthopedic device giant reported an 11.2% year-over-year increase in Q2 sales to $5.0 billion, surpassing the analysts’ anticipated revenue of $4.82 billion. Earnings were up 12.% to $738 million for the quarter […]
Smith+Nephew CFO to step down, revenue guidance increased
Smith+Nephew said today that it now expects 6–7% revenue growth this year, up from a previous 5–6% growth projection. The British orthopedic and sports medicine products company also announced that CFO Anne-Françoise Nesmes will step down during the second quarter of 2024 and that the board has initiated an external search for a successor. Revenue […]