Edwards Lifesciences Praises Updated CMS Coverage Decision for TAVR

ResMed Inc. reported fourth-quarter fiscal 2026 revenue of $1.5 billion, up 9% year over year, driven by strong demand for sleep devices, masks, and accessories. Americas device revenue rose 6%, total Americas Sleep and Breathing Health revenue rose 8%, and Americas masks and other revenue increased 10%. On September 15, RBC Capital upgraded ResMed stock to Outperform from Sector Perform and raised its price target to $262 from $244, expecting high single-digit earnings per share growth over the next three years and assuming Philips Respironics returns to the US market in fiscal 2028. The company's fiscal 2027 revenue guidance of $5.75 billion to $5.85 billion fell short of analysts' expectations of $5.92 billion, and Astral ventilator sales remain suspended following a device correction the FDA classified as a Class I recall. Hedge fund interest held steady at 45 funds in the second quarter, with Arrowstreet Capital raising its stake by 151% to approximately $220.16 million and AQR Capital Management increasing its position by 161% to approximately $177.14 million, while short interest stood at 9.06% of shares outstanding as of August 31.

IR-MED Ltd. and Dice Technologies Co., Ltd. announced the signing of a letter of intent to cooperate on the evaluation, research support, localization, commercialization preparation and regulatory preparation of IR-MED's PressureSafe medical device in Japan. The LOI is not intended to create legally binding obligations between the parties, except for provisions relating to confidentiality and data protection, intellectual property rights, and device management, return and disposal. The collaboration targets a Japanese market that includes more than 36 million people aged 65 and older, approximately 8,000 hospitals, 13,600 long-term care facilities, and 16,000 or more home-visit nursing stations. Dice Technologies, based in Osaka, will lead and coordinate the evaluation program in Japan, leveraging a nationwide footprint serving over 1,000 clinics, and will support Pharmaceuticals and Medical Devices Agency consultation preparation while integrating PressureSafe data into its CareNest platform and domestic Electronic Health Records. Clinical research and evidence-generation activities are expected to include cooperation with the Department of Plastic Surgery at Kobe University, subject to required ethics review, institutional approvals and separate written arrangements. IR-MED's PressureSafe combines infrared spectroscopy with a proprietary algorithm to support assessment of early signs of pressure injuries, and the partners intend to evaluate it in hospitals, long-term care facilities and home healthcare settings.

Apollo Global Management is reportedly in non-binding talks to acquire Johnson & Johnson's orthopaedics business, DePuy Synthes, for nearly $20bn, according to Bloomberg, which first reported the development. Anonymous sources said an agreement could be reached within several weeks, though the talks could also end without a deal or attract another bidder, and DePuy Synthes has drawn interest from several private equity companies. If signed, it would be Apollo's largest healthcare deal to date. The talks come as J&J works to separate itself from DePuy Synthes following its 2025 spinout announcement; the unit posted $9.3bn in sales last year and was created through J&J's $21bn takeover of Swiss company Synthes in 2012, which was combined with its own DePuy business. GlobalData medical devices research director Andrew Thompson called a $20bn deal a low end value, noting J&J bought Synthes in 2011 for $19.7bn and DePuy was a $3.5bn acquisition from Roche in 1998, and said a rival bid would likely come from another private equity group or consortium rather than Stryker or Zimmer due to regulatory hurdles. Neither J&J nor Apollo immediately responded to a request for comment.