Medtech stories we missed this week: September 8, 2017

From BrainScope’s pediatric traumatic brain injury assessment device to EOS Imaging releasing new surgery planning software, here are seven medtech stories we missed this week but thought were still worth a mention. 1. BrainScope to develop pediatric traumatic brain injury assessment device BrainScope announced in a Sept. 7 press release that it will immediately start creating

Medtech stories we missed this week: June 23, 2017

From Guardant suing Foundation Medicine to Interson receiving 510(k) clearance for ultrasound probes, here are medtech stories we missed this week but thought were still worth mentioning. 1. Guardant levels false advertising suit against Foundation Medicine Guardant Health announced in a June 22 press release that it has filed a lawsuit against Foundation Medicine for

FDA approves first ALS treatment in over 2 decades

The FDA recently announced that it has approved the drug Radicava (edaravone) to help treat patients who have amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. ALS is a progressive neurodegenerative disease that affects the nerve cells in the brain and spinal cord, according to the ALS Association. Motor neurons in the brain

Medtech stories we missed this week: April 28, 2017

From FDA and Health Canada approvals to joint ventures, here are medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Joimax Endovapor 2 Joimax announced in an April 26 press release that it has received FDA 510(k) clearance to market its Endovapor 2 Multi-Radio Frequency System. The device generates

Medtech stories we missed this week: April 21, 2017

From new and renewed partnerships to FDA approvals, here are medtech stories we missed this week but thought were still worth mentioning. 1. Life Spine receives FDA clearance for cervical spacer system Life Spine announced in an April 19 press release that it has received FDA 510(k) clearance for its Plateau-C Ti Cervical Spacer System. The system uses

BTG receives FDA 510(k) clearance for EKOS Control Unit 4.0

BTG, the global specialist healthcare company, announced FDA 510(k) clearance has been granted to the EKOS Control Unit 4.0. The EKOS system includes an ultrasonic device that uses acoustic pulses, powered by the new Control Unit 4.0, to quickly and safely dissolve blood clots and restore blood flow in patients with pulmonary embolism (PE), deep

Medtech stories we missed: Feb. 24, 2017

Several companies made distribution deals this week, while others received approval for their products. Here are some medtech stories we missed this week but were still worth mentioning. 1. Israel OKs E-Qure’s BST device for chronic wounds E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the

Luminex wins FDA nod to test for dangerous pregnancy infection

Luminex continues to rack up FDA clearances for assays to use in its Aries systems. The Austin, Texas–based company said Wednesday that FDA has cleared an Aries assay for group B streptococcus. It’s the third assay FDA has cleared for use with Luminex’s Aries systems. The GBS assay has also received a CE-IVD marking. Luminex

FDA and ‘emerging signals’: what you need to know

FDA will start issuing early warnings about medical devices that may be causing adverse events, under a final guidance for industry and FDA staff released this week. The plan for the agency to publicly disclose emerging safety signals drew fire from industry groups earlier this year. AdvaMed, for example, said in its public comment to

MasterControl provides FDA Readiness Toolkit

The guidelines set forth by the FDA are a major factor in ensuring that companies manufacture and sell products that are safe, reliable, and effective. But many manufacturers are so bogged down with inefficient practices that their quality systems are unreliable and out of compliance. MasterControl’s FDA Readiness Toolkit is designed to get manufacturers up

Unique results show DiviTum is able to evaluate the anti-tumor activity of blockbuster cancer drug

A U.S. study, performed by Dr. Cynthia Ma, Associate Professor of Medicine at Washington University School of Medicine, investigated 50 women with clinical stage II or III estrogen receptor positive HER2 negative breast cancer treated with anastrozole in combination with palbociclib prior to surgery. DiviTum was used to measure levels of thymidine kinase (TK) activity, an

Senate passes 21st Century Cures Act funding research and medicine

The Senate passed the 21st Century Cures Act on Dec. 7, in a 94 to 5 vote, leaving the $6.3 billion legislation for President Barack Obama to sign. “[We are] pleased that the president is intending to sign the bill,” said AdvaMed president and CEO Scott Whitaker. “Our view is it’s a great victory for

What are the 10 keys to the U.S. pathway to medical device approval?

Debra Grodt/Director of Regulatory Affairs/Medical Device and Diagnostics Novella Clinical What is a regulatory assessment? A regulatory assessment is a comprehensive review of Food & Drug Administration (FDA) regulations and similarly marketed devices to establish a framework to design a safe and effective product. Assessments include: 1) a detailed rationale for product classification; 2) applicable

What is needed to break into the U.S. market?

Jodi Scott, Partner & Chris Casolaro, Associate/Hogan Lovells US LLP  Although most medical devices enter the United States market by obtaining either 510(k) clearance or Premarket Approval (PMA), there are other paths available, which are less frequently invoked. Below are high-level descriptions of pathways available to device companies.  1) 510(k) notification Devices that present relatively low risk (i.e., such as

What does the FDA say about validating software?

Kevin Ballard/Director of Software Validation/MasterControl Software validation is required by law for companies that operate under the purview of the FDA and EMA. Companies must validate their systems (such as those for quality management and compliance) to comply with a number of regulations including 21 CFR 11, 21 CFR 210-211, 21 CFR 820, 21 CFR 600, and 21