HD Medical said today that it’s secured FDA clearance for its HD Steth, which uses artificial intelligence to enable clinicians to perform an advanced cardiac evaluation at point-of-care. The FDA clearance covers all three product classification codes of DQD, DQC and DPS for an electronic stethoscope, phonocardiograph and electrocardiograph — all combined into one device. […]
3M, MIT working on paper-based, rapid COVID-19 test
3M (NYSE:MMM) announced today that it is working with Massachusetts Institute of Technology (MIT) researchers to develop a paper-based, rapid test to detect the virus that causes COVID-19, with the potential to manufacture millions of tests per day. The test would detect viral antigens and deliver “highly accurate results within minutes” via a paper-based device, according […]
WaveFront Dynamics opens HQ in New Mexico
Ophthalmic medical device startup WaveFront Dynamics has opened a 9,800 ft2 headquarters in Albuquerque, N.M. WaveFront Dynamics CEO Dan Neal in a news release today described the one-year-old company as “not a typical seed-stage startup.” The company has a fully staffed R&D team with state-of-the-art optical labs, optometry lane, and machine shops in place to […]
PerkinElmer expects strong Q2 results from COVID-19 testing
PerkinElmer (NYSE:PKI) said today that it anticipates sales growth of approximately 12% for the second quarter, fueled by demand for COVID-19 tests and related products. The Waltham, Mass.-based diagnostic and scientific instrument company said demand for its RT-PCR and serology tests, RNA extraction systems and kits and automated liquid handling instrumentation was particularly robust. COVID-19 related […]
What kinds of COVID-19 tests are out there?
Months into the pandemic, the FDA continues to grant emergency use approval (EUA) to new tests to detect the virus that causes COVID-19 and the antibodies that indicate a person has had it. To date, the FDA has granted EUAs for 171 tests —142 molecular tests, 27 antibody tests, and 2 antigen tests. Given the ever-changing […]
Magstim acquires high-density EEG tech from Philips
Transcranial magnetic stimulation tech developer Magstim recently announced that it has purchased the product portfolio of Electrical Geodesics from Royal Philips (NYSE:PHG). Financial terms of the deal were not disclosed. Magstim will acquire EGI’s hardware, software and sensor nets assets and will immediately manage global sales, service and support, maintaining a presence in EGI’s Oregon office. […]
FDA clears Nonin Medical flagship product
Nonin Medical (Plymouth, Minn.) announced today that it has received 510(k) clearance for its flagship product — the CO-Pilot wireless handheld multi-parameter system. The handheld, wireless CO-Pilot is meant to make it easier for EMS, firefighters and military personnel to measure a person’s key vital signs following a cardiac arrest, traumatic injury, carbon monoxide or […]
Dascena wins FDA beakthrough device designation for AI to predict kidney injury
Dascena announced today that it received FDA breakthrough device designation for its Previse algorithm for predicting acute kidney injury (AKI). The artificial intelligence (AI)-based algorithm is designed to predict AKI more than a full day before patients meet the clinical criteria for diagnosis. The company touts its regulatory victory as the first breakthrough nod for […]
FDA warns of false positives with certain COVID-19 tests from BD
The FDA issued a statement today warning on an increased risk of false positive results with the BD Max System SARS-CoV-2 tests from Becton Dickinson (NYSE:BDX). The agency is alerting clinical laboratory staff and healthcare providers to the risk after a study in which the manufacturer found that approximately 3% of results from the BD SARS-CoV-2 […]
BD launches COVID-19 antigen test that can produce results in 15 minutes
Becton Dickinson (NYSE:BDX) announced today that it’s received an FDA emergency use authorization for its COVID-19 antigen test, which the company will start shipping this week. BD plans to ramp-up manufacturing capacity to 2 million tests per week by the end of September, with 10 million tests produced by the end of September. The tests run […]
Thermo Fisher projects 10% increase in Q2 sales
Thermo Fisher Scientific (NYSE:TMO) announced today that it estimates revenue growth for its recently ended second quarter to total approximately 10%. Waltham, Mass.-based Thermo Fisher said in a news release that its reported and organic sales growth for the quarter (ended June 27) was primarily driven by global sales of PCR-based tests and other products and services supporting […]
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