The US agency's Clinical Chemistry and Clinical Toxicology Devices panel showed support Aug. 10 for a de novo submission by Baebies Inc. on its Seeker System for newborn screening for lysomal storage disorders. Panelists said the need for the newborn screen outweighed the uncertainties in setting cutoff points and false-positive/false-negative rates.

FDA's Clinical Chemistry and Clinical Toxicology Devices Panel will meet Aug. 10 to address Baebies Inc.'s submission for its Seeker newborn screen to detect lysomal storage disorders. One issue on the US agency's mind in the lead-up to the meeting is how false-positive rates were determined.

Our 12th annual analysis reveals both an expansion of historical patterns of Series A financings and the emergence of a new group of heavily committed, relatively short-term investors.

$1.4 billion in Q3 device financing was slightly lower than Q2's $1.8 billion with just one IPO versus Q2's seven. Acquisitions reached a high of $23 billion and diagnostics financing increased 30% over Q2 to $1 billion, while M&A activity at $1.2 billion showed a sharp decline from the previous quarter's $15.6 billion.