NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

After a slow January, new product development picked up steam in February. Here's a rundown of the key new launches. NEWLY LAUNCHED PRODUCTS & … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

The past few weeks have brought snow to parts of the country that don't usually see the white stuff, and a flurry of diagnostic deals. Although some pundits continue to speculate about a business … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results

On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to market. Under the "Safety and Performance Based Pathway" (new Pathway), new product … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Late December through January was fairly slow for new product launches in terms of both volume and impactful-ness. Here's a rundown of the new offerings that did emerge from the pipeline: NEWLY … [Read more...]

DIAGNOSTIC DEALS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

A government shutdown, ongoing tensions with China and concerns about continued economic growth have marked the beginning of 2019. Against this backdrop, diagnostic deals continue to move forward. … [Read more...]

INDUSTRY BUZZ

FDA Watch: Agency Floats Plan to Simplify 510(k) Premarket Review

Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including diagnostics. Here's a quick … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Most of the new product launches in late November through December were in the molecular and genomics space. For the second month in a row, Qiagen was among the most active companies with a trio of … [Read more...]

NEW PRODUCTS

The Dx Pipeline: A Roundup of the Month’s Key New Product Launches

Here are some of the more notable launches from the busy October-November period. NEWLY LAUNCHED PRODUCTS & SERVICES Company(ies) Product(s)/Service(s) Quest QuestDirect, … [Read more...]

INDUSTRY BUZZ

FDA Watch: First NGS Residual Cancer Detection Test Wins Approval

The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute … [Read more...]

DISTRIBUTION AGREEMENTS

Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month

As the year winds down, diagnostic deals aren't as plentiful. Nevertheless, there have been some significant transactions. Here's a recap of the key activity from mid-October through the third week of … [Read more...]


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