MIT researchers are examining how different-sized polymer nanoparticles circulate in the body to aid in treating traumatic injuries. Researchers are developing injectable nanoparticles that can attract cells to help stop the bleeding at the site of an internal injury until a patient can reach a hospital for further treatment. In an effort to highlight the […]
Blood Management
FDA grants breakthrough nod for Datar’s early-stage prostate cancer detection blood test
Datar Cancer Genetics announced today that it received FDA breakthrough device designation for its cancer-detecting blood test. Boston-based Datar designed its TriNetra-Prostate blood test to detect early-stage prostate cancer. It follows the company’s early-stage breast cancer detection test, which garnered a breakthrough nod in November 2021. The company said in a news release that studies […]
Haemonetics posts mixed-bag Q3, tightens guidance range
Haemonetics (NYSE:HAE) shares dipped slightly before hours on third-quarter results that were mixed compared to the consensus forecast. The Boston-based company posted profits of $23.2 million, or 45¢ per share, on sales of $259.8 million for the three months ended Jan. 1, 2022, for a 27.1% bottom-line slide on sales growth of 8.1%. Adjusted to […]
Medtronic issues voluntary recall for TurboHawk 6Fr Plus directional atherectomy system
Medtronic (NYSE:MDT) today announced that it issued a voluntary recall for its TurboHawk 6 French (6Fr) Plus directional atherectomy system. The recall for the TurboHawk Plus system relates to the risk associated with tip damage caused by guidewire prolapse. A recall for the HawkOne directional atherectomy system — associated with a similar issue — was […]
BD acquires blood disease detection tech developer Cytognos
BD (NYSE:BDX) announced today that it completed the acquisition of flow cytometry solution developer Cytognos. Salamanca, Spain-based Cytognos specializes in flow cytometry solutions for blood cancer diagnosis, minimal residual disease (MRD) detection, and immune monitoring research for blood diseases. Franklin Lakes, New Jersey–based BD said in a news release that the acquisition accelerates its strategy […]
Medtronic’s recall of HawkOne system is Class I
The FDA today issued a notice confirming that the recall of Medtronic’s (NYSE:MDT) HawkOne system is Class I, the most serious kind. So far in 2022, the FDA has classified three Medtronic-related recalls as Class I, with the Covidien (part of Medtronic) Puritan Bennett 980 series ventilator and the Synergy Cranial and StealthStation S7 Cranial […]
Eurofins’ empowerDx launches at-home blood test in U.S.
Eurofins subsidiary empowerDx today launched its PFAS Exposure direct-to-consumer at-home test in the U.S. Luxembourg-based Eurofins touts the per- and polyfluorinated alkyl substances (PFAS) test as the first direct-to-consumer, at-home test for determining the levels of PFAS in a person’s blood and measure 47 of the PFAS “forever chemical” compounds. According to a news release, […]
Abiomed picks up regulatory wins in U.S., Asia
Abiomed (NSDQ:ABMD) announced today that regulators in three different countries granted new approvals to Impella surgical products. Danvers, Massachusetts-based Abiomed won FDA early feasibility study (EFS) investigational device exemption (IDE) for the Impella BTR (bridge-to-recovery), while the Impella 5.5 with SmartAssist won approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and Hong Kong’s Medical […]
FDA approves Philips’ laser-based device for removing inferior vena cava filters
The FDA today announced the authorization of the first laser-based device for removing IVC filters, developed by Royal Philips (NYSE:PHG). Authorization came through the de novo pathway, with Philips’ device receiving FDA breakthrough device designation for removing IVC (inferior vena cava) filters. Philips designed the device for patients who have an IVC (inferior vena cava) […]
OrganOx wins FDA PMA for its donor liver transport device
OrganOx announced today that it received FDA premarket approval (PMA) for its metra normothermic machine perfusion (NMP) system. Oxford, England–based OrganOx designed its metra system as a fully automated NMP device for the preservation and transport of donor livers set for transplantation. The transportable device sustains donor livers in a functioning state for up to […]
FDA grants breakthrough nod to Fist Assist Devices’ vein dilation system
Fist Assist Devices announced today that it received FDA breakthrough device designation for the Fist Assist model FA-1 device. Las Vegas-based Fist Assist touts its FA-1 device as the world’s first wearable for pre-surgical vein dilation that promotes AV fistula creation in adult patients diagnosed with chronic renal failure whose pre-operative assessment of the venous […]