Brandon Smith on Medical Devices

Objective Evidence in Determining Obviousness

MEDTRONIC, INC. v. TELEFLEX INNOVATIONS - Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board. Summary: A close prima facie case of obviousness can be overcome by strong evidence of objective...more

6/13/2023 / Intellectual Property Protection , Inter Partes Review (IPR) Proceeding , Medical Devices , Medtronic , Obviousness , Patent Infringement , Patent Litigation , Patent Trial and Appeal Board , Patents , Pharmaceutical Industry

Baxter Acquires Hillrom in the Largest Medical Device Acquisition of the Year

Baxter International Inc. (“Baxter”) has agreed to acquire Hillrom for $10.5 billion ($156 per share) in a deal expected to close in 2022. After assumption of debt, the total enterprise value of the deal is approximately...more

9/13/2021 / Acquisition Agreements , Digital Health , Innovation , Life Sciences , Medical Devices , Pharmaceutical Industry

Medtronic Gains FDA and CE Mark Clearance for LINQ II

Medtronic recently announced that it received clearance from the FDA and CE Mark approval for its LINQ II insertable cardiac monitor (ICM). The announcement notes that ICMs “are small, subcutaneously implanted devices...more

7/10/2020 / Electronic Monitoring , Food and Drug Administration (FDA) , Health Care Providers , Medical Devices , Physicians , Popular

MaxQ-AI Files for IPO

MaxQ-AI (previously known as MedyMatch) recently filed for an $8 million IPO. According to Nasdaq, MaxQ-AI filed confidentially on February 13. The prosepectus filed with the SEC describes MaxQ-AI as “a clinical stage...more

8/15/2018 / Artificial Intelligence , Emerging Growth Companies , Food and Drug Administration (FDA) , Initial Public Offering (IPO) , Medical Devices , Prospectus , Software

First Thrombectomy Device Cleared for Pulmonary Embolisms

The FDA announced 510(k) clearance for Inari Medical’s FlowTriever device for the treatment of pulmonary embolism (“PE”). According to Inari, the FlowTriever system is the first thrombectomy device cleared for the treatment...more

6/8/2018 / 510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Innovation , Medical Devices , Pharmaceutical Industry

FDA Clears First Apple Watch Medical Device Accessory

The FDA recently cleared the first medical device accessory for the Apple Watch — AliveCor’s KardiaBand. According to AliveCor, the Kardiaband is a mobile, real-time electrocardiogram (EKG) reader that can record an EKG...more

12/12/2017 / Apple , Apple Watch , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Mobile Health Apps

FDA Approves Bayer’s myBETAapp™

On May 30, 2017, Bayer announced FDA approval of a supplemental Biologics License Application for Bayer’s myBETAapp™ and BETACONNECT Navigator™. The myBETAapp joins the growing field of medical mobile applications, which the...more

6/16/2017 / Bayer , Biologics , FDA Approval , IP License , Medical Devices , Mobile Health Apps , Mobile Medical Applications

MHRA Updates Guidance on Healthcare Apps as Medical Devices

Healthcare apps are becoming a greater part of everyday life. The increasing prominence and functionality of these apps has lead to the question of when healthcare apps should be regulated as medical devices. In the United...more

10/25/2016 / App Developers , Food and Drug Administration (FDA) , Medical Devices , Medicines and Healthcare Products Regulatory Agency (MHRA) , Mobile Health Apps , UK

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

6/9/2016 / Diagnostic Tests , EU , Innovation , Manufacturers , Medical Devices , Patient Safety

FDA Issues Draft Guidance for the Use of UHMWPE in Orthopedic Devices

On February 12, 2016, the FDA issued draft guidance for the use of ultrahigh molecular weight polyethylene (UHMWPE) in orthopedic devices. The draft guidance is open for public comment for the next 90 days. According to the...more

3/30/2016 / 510(k) RTA , Draft Guidance , Food and Drug Administration (FDA) , Medical Devices

Allergan Acquires AqueSys for $300 Million

Allergan recently announced that it has completed its acquisition of AqueSys. AqueSys is a privately held company, headquartered in Orange County, California, focusing on “commercializing implantable devices that will...more

11/11/2015 / Acquisitions , Allergan Inc , Medical Devices , Pharmaceutical Industry

Brandon Smith

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