Imaging: Page 2

Baxter, digital health startups lead pushback against 510(k) exemptions

Companies argued in public comments that relaxing certain FDA regulations could put consumer safety at risk. Roche was a rare supporter, arguing the changes would "free up much needed FDA resources."

By Nick Paul Taylor • March 23, 2021

FDA approves 3D-printed ankle implant for humanitarian use

Additive Orthopaedics makes the devices from cobalt chromium alloy to treat avascular necrosis, a rare bone disease. It is the first patient-specific total talus replacement implant approved by the agency.

By Nick Paul Taylor • Feb. 18, 2021

Roundup: Medtech earnings season continues to show COVID-19 uncertainty

BD, Quest Diagnostics and Roche all said they have a clearer view of the first quarter of 2021 but not the second half of the year, while Boston Scientific forecast electives pressure in the first quarter recovering in the second half.

Siemens Q1 boosted by antigen tests, routine work normalizing

"We should not miss the fact that a fair share of this revenue growth would likely not have been there without the pandemic-related demand," CFO Jochen Schmitz acknowledged.

By Nick Paul Taylor • Feb. 01, 2021

Ventilators, imaging drive GE healthcare profits up 27% as procedures even out

"Regionally, public healthcare markets such as Europe and China have been stronger than private markets, particularly the U.S., India and Latin America," CFO Carolina Dybeck Happe told investors.

By Nick Paul Taylor • Jan. 26, 2021

Philips beats Q4 expectations as COVID-19 boosts connected care, slows procedures

The Dutch conglomerate will continue to be active on the M&A front, CEO Frans van Houten told investors, after striking two deals in the space over the past month worth more than $3.4 billion.

By Nick Paul Taylor • Jan. 25, 2021

CMS breakthrough rule called tailwind for Abbott, J&J and Medtronic

The policy gives developers of FDA-designated breakthrough products coverage for Medicare's 60 million beneficiaries on the day of approval.

By Nick Paul Taylor • Jan. 13, 2021

FDA lays out alternative 510(k) path criteria for 3 device types

The agency finalized guidance documents covering several product categories — spinal plating systems, orthopaedic bone screws and magnetic resonance coils — as it pushes forward with its Safety and Performance Based Pathway.

By Susan Kelly • Dec. 15, 2020

GE medical imaging devices impacted by critical cyber vulnerability

Dozens of products like CT scanners and MRI machines are susceptible to hackers getting access to sensitive health data and disrupting their operation, according to firm CyberMDX. GE says there is no risk to patient safety.

By Greg Slabodkin • Dec. 08, 2020

Olympus to pay $300M to buy Veran for lung navigation system

The deal is for $300 million up front, with another $40 million tied to an undisclosed milestone.

By Nick Paul Taylor • Dec. 07, 2020

MedPAC pans CMS idea to lean on commercial payers for Medicare coverage decisions

The advisory group warned against threats to transparency and rigor in response to a proposed rule defining the term "reasonable and necessary" and adding a faster coverage pathway for FDA-designated breakthrough devices.

By Susan Kelly • Nov. 03, 2020

Siemens Healthineers projects up to 8% revenue growth in FY2021

The German imaging and diagnostics giant said it won U.S. antitrust approval for its planned $16.4 billion buyout of radiation oncology specialist Varian in late October, helping the deal close in the first half of 2021.

By Maria Rachal • Nov. 02, 2020

Medtronic acquires thyroid surgery tech in 7th tuck-in deal of 2020

An addition to the medtech's pandemic-battered ENT business, Ai Biomed's PTeye system won De Novo authorization from FDA in 2018 for its ability to help surgeons spare important calcium-regulating tissue during procedures.

By Maria Rachal • Oct. 29, 2020

CMS to push back radiation oncology model after industry blowback

Agency administrator Seema Verma said a six-month delay will be formalized via upcoming rulemaking because "more time is needed to prepare."

By Susan Kelly • UPDATED: Oct. 22, 2020 at 11:07 a.m.

Surgical robots, early cancer tests top CB Insights digital health startup list

The most promising, as aggregated in annual rankings from the firm, have raised over $20 billion in total funding for more than 600 deals with 900-plus investors.

By Hailey Mensik , Maria Rachal • Aug. 14, 2020

COVID-19 diagnostics emerging as prime investment target, SVB analysis shows

Companies with tech involved in the pandemic response raised $1.3 billion over the first half of the year, with developers of tests and R&D tools enjoying a 62% increase in investment.

By Nick Paul Taylor • July 24, 2020

Philips sees double-digit COVID-19 connected care bump amid Q2 sales dip

Headwinds won out this spring, dragging total sales down 6%. Still, management predicted the return of elective procedures will help tip the balance to growth for the rest of the year.

By Nick Paul Taylor • July 20, 2020

Move to digital mammography failed to improve outcomes, study finds

A new meta-analysis shows the use of digital versus film mammograms had no effect on likelihood of a tumor being detected between screening scans, despite early hopes that digitization of the imaging tech would deliver benefits.

By Nick Paul Taylor • June 25, 2020

Philips, startups look to deploy new ultrasound tech amid coronavirus

The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.

By Nick Paul Taylor • May 14, 2020

AdvaMed pushes US to lift tariffs on Chinese imports of COVID-19 devices

The trade group wants indefinite exemptions for imaging components and devices used in ventilators, among other items. It also floated a compromise: re-imposing them one year after the pandemic passes.

By Nick Paul Taylor • April 30, 2020

FDA encourages remote review of digital pathology slides amid COVID-19

The agency's latest effort to support greater access to medical devices during the pandemic follows a move by CMS that opened the door for pathologists to work away from the lab.

By Susan Kelly • April 27, 2020

FDA moves to boost access to imaging systems during pandemic

The agency is allowing devices to be modified for portable use to enable imaging outside of hospitals in an effort to potentially slow the spread of COVID-19. 

By Nick Paul Taylor • April 24, 2020

Philips to invest $109M as COVID-19 drives connected care order growth

CEO Frans van Houten said sourcing component parts from affected suppliers has been a challenge amid increasing demand for ventilators, patient monitors and certain diagnostic devices.

By Nick Paul Taylor • April 20, 2020

FDA clears Sectra's digital pathology module for primary diagnostics as US market heats up

The clearance will intensify competition in the space initially monopolized by Philips, with big medtechs like Roche aiming to enter. The ability to review images from anywhere may be critical amid the coronavirus pandemic.

By Nick Paul Taylor • April 02, 2020

Insightec nets up to $150M for incisionless brain surgery tech

Backed by Koch Industries, the privately held medtech makes non-invasive technology that uses ultrasound to help treat ailments such as essential tremor and Parkinson’s disease.

By Greg Slabodkin • March 09, 2020