Blog Category: Blog

First Prosthetic Iris Approved

First Prosthetic Iris Approved

On May 30, 2018, the Food and Drug Administration announced the approval of the CustomFlex Artificial Iris. According to the FDA, this is the first approved artificial iris. The approval was granted to Clinical Research Consultants, Inc.,

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

Apple Releases Electronic Health Record Aggregation Tool in iOS 11.3

According to an Apple press release, iPhone users will now be able to store and view their medical records on their phones as part of a new feature found in iOS 11.3.  Although many patients are already familiar with clinic-specific patient

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

Materialise Receives First-Ever 510(k) Clearance for Anatomical Model 3D Printing Software

3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D printer at the

China FDA Issues Guidance on 3D Printed Medical Devices

More than two and a half years after the China Food and Drug Administration (CFDA) formally approved its first three-dimensional (3D) printed medical device for mass production, a hip implant co-developed by Peking University’s

KnobbeMedical Named as a “Top 30 Medical Device Blog”

KnobbeMedical.com was recently named as a “Top 30 Medical Device Blog” by Feedspot. KnobbeMedical made the list along with other respected medtech industry blogs including MassDevice and MDDI Online based on several stated

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