Imaging: Page 2

Siemens Healthineers' diagnostic sales soar on EU demand for COVID-19 tests

Antigen test revenue grew more than 200% but is now expected to drop significantly. Unlike rivals Abbott and Quidel, which have seen fast-falling sales, the German medtech primarily serves Europe.

By Nick Paul Taylor • July 30, 2021

GE Healthcare's COVID-19 recovery continues with double-digit growth in imaging, ultrasound

Second-quarter results reflect the return of elective procedures to pre-pandemic levels. A standout was its pharmaceutical diagnostics business which saw orders grow nearly 50% organically year over year.   

By Greg Slabodkin • July 27, 2021

Philips Q2 hit from sleep apnea, ventilator recall overshadows pandemic recovery

CEO Frans van Houten downplayed the potential of a significant impact on Philips' business. But, Baird analysts contend the company could lose about $800 million in the 12-month repair/replace cycle, with ResMed benefiting.

By Nick Paul Taylor • July 26, 2021

Radiation therapy 'under attack' from CMS cuts, professional body warns

Equipment manufacturers including Varian, ViewRay, Hitachi, Siemens and Elekta are among those that could also be affected by the reimbursement changes.

By Nick Paul Taylor • July 21, 2021

MDUFA talks expose 'fundamentally different' views of FDA and device companies

At the latest meeting over user fees, industry remained opposed to the agency's pitch for a Total Product Life Cycle Advisory Program, which it contends would extend the scope beyond FDA's purview. 

By Nick Paul Taylor • July 12, 2021

FDA seeks feedback on distinction between device remanufacturing and servicing

The long-awaited draft guidance is meant to clarify a blurry line between the two processes. The Medical Imaging and Technology Alliance contends remanufacturing is being done by unregulated third-party device servicers.

By Nick Paul Taylor • June 18, 2021

Cancer tech dominates FDA's latest batch of breakthrough devices

The agency's recent breakthrough designations feature a clutch of oncology devices and diagnostics from companies including Viome and Avenda Health.

By Nick Paul Taylor • June 7, 2021

Quest partners with Paige to create AI-enabled cancer pathology products

The two will initially focus on developing regulatory-approved products that support the diagnosis of solid tumors such as cancers of the prostate, breast, colorectal region and lung. 

By Nick Paul Taylor • May 26, 2021

Guidance on safety testing, labeling of devices in MR environments finalized by FDA

The agency kept the structure of the draft but changed many details about how medical device developers should test their products.

By Nick Paul Taylor • May 20, 2021

Virtual proctoring, training poised to be new normal in post-pandemic surgical interactions

Prior to the COVID-19 public health crisis, momentum to transition operating rooms into digitally connected learning environments was building. Social distancing mandates accelerated those efforts.  

By Greg Slabodkin • May 19, 2021

AI, digital health feature in latest batch of FDA breakthrough device designations

The agency granted regulatory privileges to artificial intelligence products, including software designed to enable the early detection of cancer and technology to help surgeons tell if cancer is still present after surgical excision.

By Nick Paul Taylor • May 5, 2021

Radiology Partners, Aidoc talk AI adoption, handling bias, FDA actions

While AI and machine learning technologies have gained popularity in the medtech and healthcare industries, the companies intend to further grow usage in radiology with their recent partnership.

By Ricky Zipp • May 3, 2021

Siemens raises outlook as COVID-19 antigen tests blast past original sales target

The company's bullish prospect for its rapid antigen test business comes as rivals like Abbott Laboratories and Quidel, which are more exposed to the U.S. market, fell short of expectations in the first quarter.

By Nick Paul Taylor • May 3, 2021

GE Healthcare grows sales as routine screening, elective procedures return

The results provide further evidence that the resumption of elective procedures has driven up demand for imaging and other healthcare products and services. GE saw volumes return for cardiac, oncology and neurology screening.

By Nick Paul Taylor • April 27, 2021

Philips raises guidance as elective procedures exceed pre-pandemic levels

The Dutch conglomerate's results follow encouraging rebounds in non-emergency care from Edwards, Intuitive Surgical and J&J. Still, Philips posted a loss from continuing operations. 

By Nick Paul Taylor • April 26, 2021

FDA drops 8 medical software functions from oversight

The final rule, issued without notice or comment, brings the software classifications in line with provisions of the 21st Century Cures Act and reflects the agency's current statutory authority.

By Susan Kelly • April 19, 2021

FDA scraps Trump-era 510(k) exemption bid in scathing dissection of 'flawed' plan

The agency nixed the proposal, which HHS made without consulting FDA, after strong pushback from Baxter and digital health startups, among other stakeholders, as well as its own staff.

By Nick Paul Taylor • April 16, 2021

Medtronic launches AI-based colonoscopy device in US on heels of FDA clearance

The medtech is the exclusive global distributor of Cosmo Pharmaceutical's GI Genius module, which has been granted De Novo clearance and is compatible with colonoscope video for identifying polyps and lesions. 

By Greg Slabodkin • April 12, 2021

Medtronic's robotic spine market lead threatened as smaller rivals look to edge in

Medtronic and Globus Medical are currently in a "two pony race" in the space, but market share can be stolen as other companies launch systems and adoption grows.

By Ricky Zipp • April 9, 2021

UCLA engineer calls for mitigation of biases of medical devices

The perspective in the journal Science comes as the FDA has warned of social biases in data used to train artificial intelligence and bias against Black patients using pulse oximeters.

By Nick Paul Taylor • April 5, 2021

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.

Feb. 5, 2021

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. 1, 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