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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

June 9, 2022

View Archived Issues
Breast cancer awareness

Stratipath receives CE mark for breast cancer prognostic AI

Stratipath AB gained CE-IVD mark for its artificial intelligence (AI)-based software for prognostic risk stratification of breast cancers, clearing the path for introduction of the solution in the EU. Stratipath Breast analyzes digital histopathology whole slide images generated from surgically resected breast cancer tissue to identify patients with increased risk of disease progression. The system provides clearer guidance on the best treatment path for the 50% of women whose breast cancer is categorized as intermediate risk. Read More
X100HT device from Scopio Labs

Scopio Labs lands upgraded FDA clearance for telehematology device

Tel Aviv-based startup Scopio Labs Ltd. has received U.S. FDA 510(k) clearance for its artificial intelligence (AI) powered cell morphology platform, X100HT. The laboratory device is designed to locate and display images of white cells, red cells and platelets acquired from fixed and stained peripheral blood smears. Analysis of the images is then provided using AI technology. Read More
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House passes FDA user fee bill, but conflict with Senate version looms

The U.S. House of Representatives voted June 8 to pass the legislation reauthorizing a number of user fee programs at the FDA, a welcome bit of good news for FDA-regulated industries. Nonetheless, there are several substantive differences between H.R. 7667 and the parallel Senate bill, differences that may take some doing to overcome before a final bill can be forwarded to the Oval Office. Read More
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Mittelstand Santé applies lessons learned from COVID crisis at the European level

Mittelstand Santé, a new Franco-German health-tech alliance, has just published its first compilation of feedback from executives of French and German health care companies relating to the COVID pandemic. The French contingent is developing proposals aimed at strengthening the resilience of European health care manufacturing. Read More
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India updates regulations on licenses as part of regulatory overhaul

India’s regulators have made more moves in recent times as part of its larger and ongoing movement to regulate medical devices in its country. The Ministry of Health and Family Welfare has just finalized its regulations over the licenses of medical device manufacturers and suppliers. Read More

OIG sees deficits in NIH vetting of grantees with ties to foreign governments

The issue of life science espionage continues to reverberate across the U.S., and a new report by the Office of Inspector General (OIG) suggests that vulnerabilities in the U.S. have not been adequately addressed. The OIG report said that more than two thirds of NIH grantees failed to meet at least one requirement for investigator disclosures about their activities related to foreign entities, including governments, a problem OIG says is in dire need of a fix. Read More

White House makes ‘painful’ tradeoff to prepare for fall COVID surge

The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing. Read More

Appointments and advancements for June 9, 2022

New hires and promotions in the med-tech industry, including: Gns Healthcare, Imaware, Indegene. Read More

Financings for June 9, 2022

Med-tech firms raising money in public or private financings, including: Biospring Partners, Bright Uro, Wavemaker Three-Sixty. Read More

In the clinic for June 9, 2022

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Oncologica. Read More

Other news to note for June 9, 2022

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Bluejay Diagnostics, Icecure, Onward, Sophia Genetics. Read More

Regulatory actions for June 9, 2022

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Oncologica, Medicalgorithmics, Scopio, Thermo Fisher. Read More

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