Dsruptive Subdermals AB has completed a clinical showing body temperatures tracked by its chip implants are comparable to temperature readings from standard clinical thermometers. The Stockholm-based startup is now offering its injectable implants as an open platform for researchers seeking efficient, low-cost tools to monitor changes in body temperature.
Medtronic plc is ceasing global sales and distribution of its Heartware ventricular assist device (HVAD) due to safety concerns. The news sent Medtronic shares down about 1% in early morning trading. The Dublin-based company said it made the decision to stop selling the HVAD left ventricular assist device after clinical comparisons found a higher frequency of neurological adverse events, including stroke and mortality, with its heart pump device vs. other circulatory support systems.
Edwards Lifesciences Corp. has won the FDA’s nod for its Acumen hypotension prediction index (HPI) software with the Acumen IQ finger cuff. Prior to receiving this 510(k) clearance, the low blood pressure prediction software was only available for patients using an invasive arterial line. The Acumen HPI software uses data gleaned from the Acumen IQ cuff, along with machine learning, to alert clinicians if a patient is at risk of hypotension, drops in pumping pressure that reduce the flow of oxygenated blood and nutrients to the body’s vital organs.
Veracyte Inc. has agreed to acquire Haliodx SAS in a €260 million (US$318.1 million) deal to accelerate growth and strengthen its global footprint in cancer diagnostics. The cash and stock transaction will give Veracyte a manufacturing presence in Europe and expand its cancer diagnostics scope to eight of the 10 top cancers by U.S. incidence.
The FDA has granted breakthrough device designation to Micro Interventional Devices Inc. (MID) for its Mia-T percutaneous tricuspid annuloplasty system. The company will enjoy increased communication with the agency and priority review as it pursues regulatory approval.
Lantheus Holdings Inc. has snagged FDA approval for Pylarify (piflufolastat F 18), a PET imaging agent for the identification of suspected metastasis or recurrence of prostate cancer. The company said the product will be available immediately in the mid-Atlantic and southern regions, with availability across the U.S. by the end of 2021.
Digital therapeutics startup Akili Interactive Inc. has secured $160 million in a combined equity and debt financing to accelerate commercialization of its Endeavorrx platform for cognitive disorders. The company won FDA clearance and the CE mark in June 2020 for its video game-based treatment, Endeavorrx ALK-T01, for children with attention deficit hyperactivity disorder (ADHD).
A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists.
Veriskin Inc. has emerged from stealth mode with a noninvasive technology for skin cancer diagnosis and screening. The hand-held device, called Truscore, is designed to help nonexpert users quickly ascertain if a suspicious skin lesion is cancerous. Truscore works by detecting and interpreting force-induced hemodynamic differences between normal and malignant skin sores. It uses a proprietary artificial neural network-based artificial intelligence algorithm and protocols to differentiate skin cancers from other harmless skin conditions.
Restoring blood flow to limbs is a challenging goal, given the minuteness of the peripheral vasculature. But there is a huge unmet need for patients with chronic limb-threatening ischemia (CLTI) – a severe form of peripheral artery disease in which patients face major amputation. Now, Limflow SA reports one-year data from the PROMISE I study shows its Percutaneous Deep Vein Arterialization System (pDVA) led to sustained amputation-free survival and wound healing in CLTI patients treated with the device.
