The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
Bruker Corp. signed a definitive agreement to acquire functional cell biology company Phenomex for $108 million as part of its Project Accelerate 2.0 strategy, which increases focus on the company’s emerging proteomics and spatial biology business. Bruker offered $1 per share, a 150% premium over the 40 cents per share closing price of Phenomex stock on Aug. 16. The all-cash transaction is slated to close in the fourth quarter of 2023.
Lush vegetation is great for a gardener, but alarming for a cardiologist. For them, the news that Angiodynamics Inc. received U.S. FDA breakthrough device designation for its Angiovac system to remove vegetation from the right heart is surely cheering. Right heart vegetations--masses of fibrin, platelets and infectious pathogens--are indications of serious infective endocarditis.
Dermasensor Inc.’s elastic scattering spectroscopy device appears to have solved one of the more challenging issues in dermatology—early detection of skin cancers in individuals with darker skin tones. The device demonstrated very high sensitivity across all skin cancer types compared to histopathological exams with minimal variation between Fitzpatrick skin type groups in an analysis of the DERM-SUCCESS trial.
Accuray Inc. offered a classic good news-bad news set-up for investors on Wednesday, with a notable FDA 510(k) clearance balanced by a miss on fourth quarter revenue and projections for fiscal year 2024 significantly below consensus expectations. Still, the takeaway is generally positive, with several strong catalysts expected to build momentum for the company in the coming year and much of the underperformance attributable to foreign exchange headwinds that have plagued many med-tech companies.
Rewalk Robotics Ltd. took strides to expand its portfolio—and achieve profitability—with an agreement to acquire Alterg Inc., a provider of anti-gravity systems for use in physical and neurological rehabilitation. Alterg uses NASA-derived differential air pressure (DAP) technology to reduce gravity’s effects on individuals with mobility challenges and pain. The $19 million deal is expected to close August 11, with additional cash earnouts tied to future revenue growth over the next two years.
The growing number of drugs gaining U.S. FDA approval for Alzheimer’s disease has kept their ability to reduce amyloid beta and tau proteins in the news, but the degenerative disease is not simply a matter of tangles and deposits. A loss of synaptic plasticity and disrupted neural networks underlie the signature impairment of memory and cognition – and those, researchers showed in a recent study in Brain, can be strengthened by non-invasive stimulation that addresses the brain’s electrical dysfunction.
A more than three-year commercial hold built up an estimated $1 billion in demand for Becton, Dickinson and Co.’s (BD) Alaris infusion system and BD has every intention of meeting that demand as quickly as possible now that it has FDA clearance for the updated device. The clearance allows the company to resume commercial sales and undertake remediation of its installed base of point-of-care units with enhanced features for its pumps and monitoring systems as well as new software and upgraded cybersecurity and interoperability.
T2 Biosystems Inc. received a third FDA breakthrough device designation with its direct-from-blood molecular diagnostic test for Candida auris. The test joins its T2resistance panel and T2Lyme panel in gaining the breakthrough recognition and the increased access to the FDA that comes with it as the company seeks final approval or clearance. The C. auris test enables identification of the challenging pathogen in three to five hours instead of the several days often required to grow a culture traditionally.
Twelve years on, Vitalconnect Inc. continues to connect well with investors, raising $30 million in an oversubscribed series F in a still-tight market just 18 months after closing its last $39 million round and less than a year after receiving venture financing from Health Insight Capital, the investment arm of HCA Healthcare Inc. The new funds will support continued growth of the company’s wireless patient monitoring systems, which are used in hospital and home settings.
