Acutus Medical (Nasdaq:AFIB) announced today that it launched an expanded suite of left-heart access products. Following expanded FDA clearance, Acutus launched the suite to now include the AcQCross Qx system for use with the TruSeal and FXD delivery system for the Boston Scientific Watchman left atrial appendage closure device. Carlsbad, California-based Acutus designed the AcQCross […]
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They said it at DeviceTalks Boston
Medtech insiders convened at DeviceTalks Boston 2022 in May to discuss device design, innovation and trends shaping the industry now and in the years and decades ahead. Here are some of the most quotable insights from panelists and speakers at our live event. And make sure to save the date — and save your seat […]
Haemonetics completes move to new Pennsylvania manufacturing facility
Haemonetics (NYSE:HAE) announced today that it fully commenced operations at its new manufacturing center in Clinton, Pennsylvania. Boston-based Haemonetics previously operated at a manufacturing plant in nearby Leetsdale, Pennsylvania, from 1990 until now. According to a news release, the custom-built facility constitutes approximately 200,000 square feet in Clinton Commerce Park near Pittsburgh International Airport. Initial […]
Another Medtronic HVAD recall is serious
A year after Medtronic ceded the LVAD market to Abbott, it has yet another Class I recall involving HeartWare Ventricular Assist Device pumps still implanted in patients. The FDA today designated a Medtronic recall involving the HVADs as Class I, the most serious level. It’s the second Class I recall designation for the HVADs this […]
Baxter’s Volara lung therapy system recall is Class I
The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind. Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint […]
BD voluntarily recalls intraosseous products
BD (NYSE:BDX) announced that it issued a voluntary recall for select lots of a trio of its intraosseous products. Franklin Lakes, New Jersey-based BD’s recall covers its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers. According to a news release, certain lots within the expiration date of the affected products may […]
How SeaStar’s device calms hyperinflammation — and could prevent lasting damage from COVID cytokine storms
SeaStar Medical recently won FDA breakthrough device designation for a new way to treat hyperinflammation with technology that could help fight chronic conditions from COVID-19 infections. The Denver-based medical developer is seeking a humanitarian device exemption for treating children with acute kidney injury (AKI) based on an FDA-funded study, SeaStar President and CEO Eric Schlorff […]
Illumina, Merck launch test for cancer development, progression insights
Illumina (Nasdaq:ILMN) announced today that it launched a new research test, co-developed with Merck (NYSE:MRK). The jointly developed test adds the assessment of a new genomic signature to the already distributed TruSight Oncology 500 assay, enabling researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous […]
Abbott to open new offices in downtown Chicago
Abbott (NYSE: ABT) will open offices in the iconic Willis Tower in downtown Chicago, a company spokesperson confirmed to MassDevice. The company’s headquarters will stay in the northern suburbs, in Lake County, but the new downtown space will help accommodate flexible working arrangements for up to 450 Abbott employees, according to company spokesperson Scott Stoffel. […]
FDA grants breakthrough nod for Carthera’s SonoCloud-9
Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system. Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound […]
Teleflex enrolls first patient in vascular closure device study
Teleflex (NYSE:TFX) announced today that it enrolled the first patient in a clinical study of its Manta vascular closure device. In the study, Wayne, Pennsylvania-based Teleflex intends to demonstrate the safety of Manta ultrasound-guided closure without dependence on the pre-procedural depth locator measurements. According to a news release, the study will enroll up to 150 […]
