A free resource by Knobbe Martens for people who are exploring a start-up, joint venture or spin-off in the medical device industry. Tweets aren't legal advice.
Join HGF and @KnobbeMartens webinar on 9 Jun, where we will explore considerations for implementing an effective strategy to secure #patentprotection for #personalisedmedicaldevices, with a particular focus on comparing the European and US jurisdictions: https://t.co/pTbGM4Jfzc
UCLA Biodesign Launches Study to Help Advance MedTech and Digital Health Innovation. Learn more and schedule an interview to participate as a thought leader at: https://t.co/RGErz0ltWv, or contact a member of the team @ [email protected].
New Blog Post: FDA Approves Blood Test for Concussion - The U.S. Food and Drug Administration has announced approval of Banyan Biomarkers, Inc.’s Banyan BTI (Brain Trauma Indicator) under the FDA’s De Novo premarket review pathway. According to the ... https://t.co/WJOTPw6fhS
New Blog Post: Johnson & Johnson Acquires French Surgical Tech Firm Orthotaxy - On February 20, 2018, Johnson & Johnson Medical Devices Companies announced the acquisition of Orthotaxy, a privately-held developer of software-enabled surgery technologi... https://t.co/X7lhy7u4ME
New Blog Post: Improper Markush Rejection: The New Kid on the Patent Block - The U.S. Patent and Trademark Office (“USPTO”) quietly increased the examiners’ arsenal by slipping a new rejection into the latest revision of the Manual of Patent Examining... https://t.co/LY36ZOt4iq
New Blog Post: Xeris’ Pharmaceuticals Glucagon Progresses Towards FDA Approval - Xeris Pharmaceuticals, Inc. (“Xeris”) recently announced successful completion of both adult and pediatric clinical studies for its glucagon rescue pen. According to Xeri... https://t.co/oU87wZcTBo
New Blog Post: FDA Approves NorthStar’s Tc-99m Generator - The Food and Drug Administration recently announced approval of the RadioGenix™ System, a technetium 99m (Tc-99m) generator. The RadioGenix™ System is developed by NorthStar Medical Radioisoto... https://t.co/84BcODcYTj
New Blog Post: Seizure-Detecting Smart Watch Given FDA Approval - The FDA has recently approved Embrace, a smart watch designed to monitor epileptic patients for seizures, according to a press release. According to the press release, the device uses m... https://t.co/H626CIhj3X
New Blog Post: European Commission Proposes Stronger Cooperation for Health Technology Assessment - On January 31, 2018, the European Commission adopted a legislative proposal with the aim of strengthening EU cooperation among Member States when condu... https://t.co/ldhsw3q9i4
New Blog Post: District Court Awarded Ultrasound Device Maker Verasonics $5.6 Million And World-Wide Injunction In Trade Secret Case - The United States District Court of Western District of Washington entered a judgment in a trade secret case, Veraso... https://t.co/aaPdjw6Zoe
New Blog Post: BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration - BioArctic AB, a public Swedish biopharma company, recently announced that they received allowance of a patent application ... https://t.co/R3eQedaurp
New Blog Post: $50 Million Lawsuit Filed Against FDA - On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was filed by Semler Research Center Pv... https://t.co/annvLhrrKF
New Blog Post: Boston Scientific Announces Agreement for Investment & Acquisition Option with Transcatheter Annuloplasty Ring Developer Millipede, Inc. - Global medical device company Boston Scientific has announced on January 24, 2018, an agreement t... https://t.co/1V4nsQxBwO
New Blog Post: Akili Interactive Announces Trial Results for Video Game Treatment of ADHD - Akili Interactive recently announced results of a trial on the company’s digital medicine product, AKL-T01. According to FierceBiotech, Akili plans to file AK... https://t.co/HHnrHvCUln
New Blog Post: FDA Issues Draft Guidance for “Least Burdensome” Approach to Device Regulation - The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applicatio... https://t.co/2dc2mJOMrj
New Blog Post: FDA Approves Prickless Glucose Monitoring System - The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients. The glucose monitoring tool will... https://t.co/G0EnzOHP88
New Blog Post: FDA Pre-cert Program for Lab-Developed Tests - The FDA may begin certifying the laboratories that produce lab-developed tests (“LDTs”) instead of drafting regulatory rules to cover the tests themselves. The American Clinical Laboratory... https://t.co/uuqOvNExBn
New Blog Post: Report Finds European Union’s Assessment of High-Risk Medical Devices of Low Quality - A report appearing in the December 2017 issue of Value in Health, (a journal of the International Society for Pharmacoeconomics and Outcomes Research... https://t.co/pxQF9PUiJA
New Blog Post: Microbot Medical to Acquire CardioSert’s Technology - Microbot Medical Inc. announced that it entered into an agreement with CardioSert Ltd. to acquire CardioSert’s patented guidewire technology, including R&D information, technical kno... https://t.co/AzODiv2GlF
New Blog Post: Diabetes Monitoring Technology Moving Toward Consumer Convenience - The FDA recently approved Abott’s FreeStyle Libre Flash Glucose Monitoring System. According to Bloomberg, this device marks the first continuous glucose monitoring sy... https://t.co/ToujNCMmdx