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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

May 28, 2021

View Archived Issues
patent-law.png

De novo petitions not the same as patent protection, but some exclusivity available

Medical devices have had to deal with a large body of uncertainty where patent protection is concerned, thanks principally to jurisprudence arising out of the Supreme Court. However, Mark Mansour, a regulatory attorney with the D.C. office of Dykema Gossett PLLC, said on a recent webinar that even in the absence of a patent, de novo devices can gain some market exclusivity with smart use of labeling, a practice that can help ensure that the developer can achieve the needed return on investment. Read More
Scopio's digital blood smear analysis tool

Scopio re-envisions blood analysis

Hematologists juggle two competing needs, and often multiple lenses, to really see what’s happening in a blood sample. Essentially, they need to see both the veins on an individual leaf and the forest, but lack a digitized system that can provide images of both. Scopio Labs Ltd.’s recently FDA-approved X100 with Full Field Morphology Peripheral Blood Smear (FFM-PBS) application addresses this need by combining computational photography imaging with artificial intelligence tools. Read More
Surgeon wearing Arthrolense's mixed reality surgical guidance system

Arthrolense wins $2M for hologram-based surgical guidance system

TORONTO – Arthrolense Inc. has just seen its bank balance swell after Lynx Equity Ltd. invested $2 million to further develop the startup’s augmented, mixed reality surgical guidance systems for hip and knee replacement. According to orthopedic surgeon and company CEO David Backstein the Arthrolense system uses vastly improved hologram-based technologies to solve problems that persist in computer navigation and robotic systems. Read More
3D heart illustration showing tricuspid and bicuspid valves

Micro Interventional Devices scores FDA breakthrough nod for tricuspid regurgitation treatment

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. Read More
US-budget-spending-money.png

Biden’s budget proposal includes 10% increase for FDA

The Biden administration released its full budget proposal for fiscal year 2022, increasing the FDA’s budget authority to nearly $3.6 billion, up 10% over 2021. The Alliance for a Stronger FDA said that though analysis is needed to parse out the details, the proposal will be supported. Read More
Lumakras

Amgen scores FDA approval of Lumakras in KRAS G12C-mutated NSCLC

Well ahead of the assigned Aug. 16 PDUFA date, Amgen Inc. bagged accelerated clearance from the FDA for Lumakras (sotorasib), the first targeted therapy for adults with KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC), as determined by an FDA-approved test. Read More

Holiday notice

BioWorld's offices will be closed in observance of Memorial Day in the U.S. No issue will be published Monday, May 31. Read More

Appointments and advancements for May 28, 2021

New hires and promotions in the med-tech industry, including: Lucira Health. Read More

Financings for May 28, 2021

Med-tech firms raising money in public or private financings, including: Electromed. Read More

In the clinic for May 28, 2021

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

Med-tech gainers and losers for May 24-28, 2021

The top 10 med-tech stock gainers and losers for the week. Read More

Other news to note for May 28, 2021

Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Guardant Health, Hoffmann-La Roche, Medi-Tate, Medtronic, Natera, Olympus, Qiagen, Titan Medical, Zhongchao. Read More

Regulatory actions for May 28, 2021

Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Guardant Health, Intelligent Implants, Thermo Fisher Scientific. Read More

BioWorld MedTech Patent Highlights: Week 20

BioWorld MedTech presents Patent Highlights, an excerpt of the most important med-tech patents from this week's Cortellis Patents Gazette. Read More

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