Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, this new bimonthly Pacts In Medtech column pulls up notable technology alliances, R&D partnerships and commercial collaborations. This month we highlight deals announced in July and August 2016.
Go to Strategic Transactions to get more details about deals in the medtech, pharma and biotech industries.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
The US FDA has given up on its effort to regulate lab-developed tests as medical devices, at least for now. The agency will not appeal a decision from the Eastern District of Texas that tossed out the FDA’s final rule, leaving the agency with few cards.
SAGA Diagnostics has launched its breast cancer residual and recurrence detection test – Pathlight – in the US. The test’s ultrahigh sensitivity and specificity is rare to see in oncology, the company claimed.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Guardant Health introduces a new germline panel test to help guide cancer treatment, assess the risk of secondary cancers in patients and identify family members at risk of cancer.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
Cardiosense has launched a nationwide clinical study, SEISMIC-HF II, to validate its non-invasive, AI-powered technology for monitoring heart failure. The data will be used to file for US regulatory clearance of the Cardiosense heart failure monitoring platform.
Handheld diagnostics are more powerful, accessible and clinically relevant than ever. Medtech Insight spoke to companies behind such technologies to learn how they work and discuss their commercial models.
