Blog Category: Blog

FDA Approval for Auris’ Robotic Endoscopy Platform

On March 23, Auris Health, Inc. announced FDA clearance for the Monarch Platform, Auris’ new system for robotic endoscopy. According to Auris Health, the Monarch Platform “integrates the latest advancements in robotics,

Theranos Charges Provide Perspective for Medical Device Companies, Biotechnology Companies, and Investors

On March 14, 2018, the Securities and Exchange Commission (SEC) announced it filed charges against the founder and CEO of Theranos Inc., Elizabeth Holmes, and its former president, Ramesh Balwani.

Theranos describes itself as a privately

FDA grants De Novo Market Clearance of Artificial Intelligence Software

According to a U.S. Food and Drug Administration press release, Viz. AI Contact application was granted De Novo premarket review to Viz.AI’s LVO Stroke Platform. According to PR Newswire, Viz.AI’s LVO Stroke Platform 

First Ever Marijuana-Related Medical Device Approved

First Ever Marijuana-Related Medical Device Approved

According to PR Newswire, the Israeli Ministry of Health has granted initial approval to Tel-Aviv-based Kanabo Research for their VapePod vaporizer product as a medical device. PR Newswire notes that with this approval, Israel has become

23andMe Wins FDA Approval for Test to Detect BRCA Mutations

The U.S. Food and Drug Administration (FDA) recently authorized 23andMe to market its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants).  According to an FDA news release, the approved test is the

Cyborg-Enhanced Physical Therapy Approved

Cyberdyne, Inc. recently announced FDA marketing approval for its Medical HAL [Hybrid Assistive Limb] therapeutic device and services.  Cyberdyne describes itself as a Japanese company founded by Professor Yoshiyuki Sankai of the University

EKG Monitor May Be Included in Future Apple Smart Watches

EKG Monitor May Be Included in Future Apple Smart Watches

According to Bloomberg, Apple, Inc. is currently developing an electrocardiogram (also known as an EKG or ECG) feature in its smartwatch products. A report from Bloomberg and other sources have stated that the unit in development requires

Boston Scientific Announces Acquisition of EMcision

Boston Scientific Announces Acquisition of EMcision

On March 5, 2018, Boston Scientific announced its acquisition of EMcision, a privately held company in the United Kingdom and Canada. According to Boston Scientific, this acquisition will expand its range of medical devices in the field

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 Xeris’ President and CEO Paul Edick:

Xeris is

U.S. to Have its Own Supply of the Most Commonly Used Medical Imaging Isotope for the First Time in 30 Years

Medical imaging isotopes are used to diagnose various diseases, such as cancer and coronary artery disease, and to evaluate brain, lung, kidney, and liver function.  According to an U.S. Food and Drug Administration (FDA) press release

FDA Clears New Surgery Infection Control System

FDA Clears New Surgery Infection Control System

The FDA recently cleared Prescient Surgical’s CleanCisionTM  Wound Retraction and Protection System (CleanCisionTM), a retractable device designed to prevent surgical site infection. According to Prescient Surgical, CleanCision

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 machine learning to monitor patients for dangerous seizures,

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 conducting a Health Technology Assessment (HTA) of new medicines and certain new medical

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, Verasonics, Inc. v. Alpinion Medical Systems Co., Ltd. (Case No. 2:14-cv-01820-JCC). The district court confirmed the final arbitration

Wright Medical Group N.V. announces $88 million Acquisition of IMASCAP SAS

Wright Medical Group recently announced the acquisition of IMASCAP SAS for $88 million. According to the press release, Wright Medical Group (NASDAQ: WMGI) is a publicly traded company focusing on extremity joint replacement and bio-orthopedic

BioArctic Announces Patent Allowance Entitled Spinal Cord Devices and Methods for Promoting Axonal Regeneration

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 directed to a method of promoting axonal regeneration using a biodegradable spinal cord device. The medical device

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

MedyMatch Intracranial Hemorrhage Detection Software Receives Expedited FDA Review

Tel Aviv-based MedyMatch Technology recently announced it has received Expedited Access Pathway (EAP) designation from the FDA for its intracranial hemorrahage (ICH) detection software medical device.

According to Gene Saragnese,

$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 Pvt. Ltd., a contract research organization

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 to make a $90 million investment in privately-held medical device company Millipede, Inc.  Millipede has developed a non-invasive

Da Volterra Develops Device to Combat Antibiotic Resistance

Da Volterra, a biotech company developing products in the antibacterial field, has announced results in a human clinical trial for DAV132, a product said to prevent life-treating bacterial infections during antibiotic treatments.