MASSDEVICE ON CALL — U.S. medical device makers lauded India’s healthcare officials for progress on a bill that would for the 1st time separate medical device regulation from pharmaceuticals.
The bill was introduced last year and then referred to a standing committee. The committee’s recommendations were tabled in December and are now under review by India’s union health ministry, according to the Indo-Asian News Service.
The revisions were welcomed by U.S. medical device industry lobby AdvaMed, which called for progress on the bill.
"The medical device industry welcomes the ministry’s recognition of the critical need to differentiate medical devices from pharmaceutical products in the regulatory structure, and as a vital element of the Indian health care delivery system," AdvaMed global strategy & analysis executive vice president said. "We believe the revised bill will improve industry’s ability to serve India’s growing health care needs in a safe, effective and timely manner. We commend and appreciate the government’s willingness to consult all stakeholders on this very important legislation."
Equal footing for open, lap and robotic prostatectomies
Swedish researchers report little different in readmission rates for patients undergoing radical prostatectomy via open surgery, minimally invasive laparoscopy or robot-assisted surgery.
Read more
Medical IT companies resist FDA
Companies working on medical information systems and electronic health records fight "medical device" classification, saying that hefty regulatory oversight will prevent them from making progress in digital health tools that may be vital to the healthcare industry.
Read more
J&J and Medtronic test supply chain waters with hospital pilot
Medical device giants Johnson & Johnson (NYSE:JNJ) and Medtronic (NYSE:MDT) teamed up with hospital groups to pilot a supply chain program that aims to lower healthcare costs through use of an experimental software that automates the ordering process.
Read more
